In response: “A novel cause of rebreathing carbon dioxide related to removed CLIC-seal on the Dräger Apollo© Anesthesia Machine” from B. Nikman et al. in this issue of JCMC

In response: “A novel cause of rebreathing carbon dioxide related to removed CLIC-seal on the... Journal of Clinical Monitoring and Computing https://doi.org/10.1007/s10877-018-0162-z LE T TER TO  THE   EDITOR In response: “A novel cause of rebreathing carbon dioxide related to removed CLIC-seal on the Dräger Apollo© Anesthesia Machine” from B. Nikman et al. in this issue of JCMC 1 1 2 Hans Ulrich Schüler  · Björn Goldbeck  · David Karchner Received: 10 April 2018 / Accepted: 22 May 2018 © The Author(s) 2018 We would like to thank the Editor of this Journal for giv- seal ring in the middle of the CLIC adapter is designed to be ing us as the manufacturer the opportunity to respond to positioned firmly inside the CLIC adapter. It is required in this presented case of a missing rubber seal ring leading to order to guide the gas flow inside the CLIC absorber in the increased levels of etCO . specified way (see Fig.  3). The authors describe two cases of laparoscopy cholecys- The seal ring is specified, tested, and validated to work tectomy (1). They describe, that the first case started une - in the specified way, to guide the gas flow through the filled ventful. Later on during the case, they observed increased CLIC absorber in order to bind the exhaled C O from the FiCO values; therefore during the case they removed the patient. In case the seal ring is missing, there will be an CLIC absorber from it’s fitting system (CLIC adapter), and internal leakage, creating a “pneumatic short cut” inside the shook it. After re-installing the same CLIC absorber, they CLIC absorber. In this case no C O will be removed, as the observed, that the FiCO values remained high even after CO enriched gas flows from the patient and breathing bag 2 2 shaking the absorber. Therefore, they decided to remove the do not pass the soda lime inside the absorber (see Fig. 4). absorber completely, and installed a new one. However, after Therefore we can assume the following: The reported installing the new CLIC absorber, they observed increased symptom was most likely caused by a missing rubber seal, FiCO levels of higher than 10. which is part of the CLIC adapter system and located on The CLIC adapter system is an optional feature for all the bottom side of the CLIC adapter, facing to the CLIC Dräger anesthesia workstations to allow for fast and easy absorber. The function of this seal ring is to guide the gas exchange of the entire pre-filled soda lime canister, without flow through the absorber such, that the gas passes the soda the need to empty and refill a traditional soda lime canister. lime, and to avoid a direct connection between inlet and In order to exchange this CLIC absorber, the following outlet port of the absorber canister. It is an integral part of steps have to be taken, which are also described in the rel- the CLIC system and must not be removed by the user. evant Instructions for Use of the CLIC absorber 800+/CLIC Over the life of the Apollo, we have received worldwide adapter, and also put as an explanatory label on each CLIC only a small number of reports where this seal ring was absorber itself (Fig. 1). lost/displaced. The cause was typically due to high forces The authors describe, that upon observation they found a and wrong usage of the CLIC absorber and CLIC mecha- seal ring from the CLIC adapter missing (Fig. 2). nism when closing the CLIC, or due to the health institution This seal ring is an integrated part of the CLIC adapter, incorrectly assembling the CLIC adapter following preven- and not intended to be removed, neither during cleaning tive maintenance/cleaning, often in combination when the nor during any other procedure. The CLIC adapter is main- CLIC absorber did not get exchanged after 4 years, and plas- tenance free and needs to be exchanged after 4 years (see tic material of the seal ring got aged. Instructions of Use CLIC absorber 800+/CLIC adapter). The Prerequisite for a successful device check is that the workstation has been prepared and assembled correctly. The user has to acknowledge the completeness of the breathing * Hans Ulrich Schüler system as part of the checklist implemented in the device hansulrich.schueler@draeger.com software prior to start the automatic device check. The CLIC 1 adapter with seal ring is part of the breathing system. This Drägerwerk AG & Co KGaA, Lübeck, Germany Draeger Medical, Inc., Telford, PA, USA Vol.:(0123456789) 1 3 Journal of Clinical Monitoring and Computing Fig. 1 Extract from the Instructions for Use (CLIC absorber 800+/CLIC adapter): steps to exchange the CLIC absorber Fig. 3 Gas flow inside the Apollo breathing system, with proper posi- Fig. 2 Missing seal ring on the left side CLIC adapter tioned seal ring procedure shall assure that the breathing system is complete To assist our users and further reduce the likelihood of prior to operation. such use failures, Dräger made the following changes to sig- If the inner seal ring of the CLIC adapter is missing, as nificantly reduce the opportunity of this finding reoccurring: in the described case, the integrated gas measurement of the device ensures that the high inspiratory CO concentra- In the middle of 2008, Dräger migrated from the “old tions are detected and alarmed immediately. One cause for style” CLIC adapter to the “new style” CLIC adapter. this event may be that there is an internal leak or fault in the The significance of this migration is that the “new style” breathing system, as stated in the Instructions for Use of the CLIC adapter is to be replaced every 4 years, and no Dräger Apollo© Workstation, in the chapter “Fault-Cause- longer requires preventive maintenance. This eliminates Remedy”. A remedy to this cause is to replace the breathing the concern of the CLIC adapter being reassembled system which includes the CLIC adapter. 1 3 Journal of Clinical Monitoring and Computing have already migrated to the new design (as long as the 4 year replacement strategy defined by Dräger is being followed). For customers with Apollos including the CLIC option shipped prior to June of 2008 (and have yet to migrate to the “new style” CLIC adapter), a migra- tion could be considered. Again, we have received very few reports similar to this submission, but this migration option is available. The part number for the “new style” CLIC adapter is MX50090. While Dräger did not have the opportunity to inspect this Fig. 4 Schematic of the breathing system with missing seal ring: machine, based on the images provided, the case described pneumatic short cut inside the CLIC absorber which leads to no CO by Nikman et  al. shows a CLIC adapter manufactured removal between mid 2008 and end of 2013. As a summary we very much thank the authors Nikman incorrectly by the institution following preventive main- et al. to bring this case to the attention of the readers of tenance. this journal. The submission provided an overview how the At the end of 2013, Dräger further improved the design device’s integrated gas measurement ensured that the high of CLIC adapter to include adhesive to this seal. This inspiratory CO concentrations were detected and alarmed new design eliminates the opportunity for the scenario immediately. In addition, the submission highlighted the described by the author to occur via high forces or during importance of proper training and servicing according to cleaning. What this means is: the Instructions for Use. Open Access This article is distributed under the terms of the Crea- All Apollos shipped with the CLIC option after end tive Commons Attribution 4.0 International License (http://creat iveco of 2013 include this new design which includes the mmons.or g/licenses/b y/4.0/), which permits unrestricted use, distribu- new adhesive to this seal. tion, and reproduction in any medium, provided you give appropriate • Apollos shipped with the CLIC option between 2008 credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. and 2013 with the “new style” CLIC adapter should 1 3 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Clinical Monitoring and Computing Springer Journals

In response: “A novel cause of rebreathing carbon dioxide related to removed CLIC-seal on the Dräger Apollo© Anesthesia Machine” from B. Nikman et al. in this issue of JCMC

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Springer Netherlands
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Copyright © 2018 by The Author(s)
Subject
Medicine & Public Health; Anesthesiology; Intensive / Critical Care Medicine; Statistics for Life Sciences, Medicine, Health Sciences
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1387-1307
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10.1007/s10877-018-0162-z
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Abstract

Journal of Clinical Monitoring and Computing https://doi.org/10.1007/s10877-018-0162-z LE T TER TO  THE   EDITOR In response: “A novel cause of rebreathing carbon dioxide related to removed CLIC-seal on the Dräger Apollo© Anesthesia Machine” from B. Nikman et al. in this issue of JCMC 1 1 2 Hans Ulrich Schüler  · Björn Goldbeck  · David Karchner Received: 10 April 2018 / Accepted: 22 May 2018 © The Author(s) 2018 We would like to thank the Editor of this Journal for giv- seal ring in the middle of the CLIC adapter is designed to be ing us as the manufacturer the opportunity to respond to positioned firmly inside the CLIC adapter. It is required in this presented case of a missing rubber seal ring leading to order to guide the gas flow inside the CLIC absorber in the increased levels of etCO . specified way (see Fig.  3). The authors describe two cases of laparoscopy cholecys- The seal ring is specified, tested, and validated to work tectomy (1). They describe, that the first case started une - in the specified way, to guide the gas flow through the filled ventful. Later on during the case, they observed increased CLIC absorber in order to bind the exhaled C O from the FiCO values; therefore during the case they removed the patient. In case the seal ring is missing, there will be an CLIC absorber from it’s fitting system (CLIC adapter), and internal leakage, creating a “pneumatic short cut” inside the shook it. After re-installing the same CLIC absorber, they CLIC absorber. In this case no C O will be removed, as the observed, that the FiCO values remained high even after CO enriched gas flows from the patient and breathing bag 2 2 shaking the absorber. Therefore, they decided to remove the do not pass the soda lime inside the absorber (see Fig. 4). absorber completely, and installed a new one. However, after Therefore we can assume the following: The reported installing the new CLIC absorber, they observed increased symptom was most likely caused by a missing rubber seal, FiCO levels of higher than 10. which is part of the CLIC adapter system and located on The CLIC adapter system is an optional feature for all the bottom side of the CLIC adapter, facing to the CLIC Dräger anesthesia workstations to allow for fast and easy absorber. The function of this seal ring is to guide the gas exchange of the entire pre-filled soda lime canister, without flow through the absorber such, that the gas passes the soda the need to empty and refill a traditional soda lime canister. lime, and to avoid a direct connection between inlet and In order to exchange this CLIC absorber, the following outlet port of the absorber canister. It is an integral part of steps have to be taken, which are also described in the rel- the CLIC system and must not be removed by the user. evant Instructions for Use of the CLIC absorber 800+/CLIC Over the life of the Apollo, we have received worldwide adapter, and also put as an explanatory label on each CLIC only a small number of reports where this seal ring was absorber itself (Fig. 1). lost/displaced. The cause was typically due to high forces The authors describe, that upon observation they found a and wrong usage of the CLIC absorber and CLIC mecha- seal ring from the CLIC adapter missing (Fig. 2). nism when closing the CLIC, or due to the health institution This seal ring is an integrated part of the CLIC adapter, incorrectly assembling the CLIC adapter following preven- and not intended to be removed, neither during cleaning tive maintenance/cleaning, often in combination when the nor during any other procedure. The CLIC adapter is main- CLIC absorber did not get exchanged after 4 years, and plas- tenance free and needs to be exchanged after 4 years (see tic material of the seal ring got aged. Instructions of Use CLIC absorber 800+/CLIC adapter). The Prerequisite for a successful device check is that the workstation has been prepared and assembled correctly. The user has to acknowledge the completeness of the breathing * Hans Ulrich Schüler system as part of the checklist implemented in the device hansulrich.schueler@draeger.com software prior to start the automatic device check. The CLIC 1 adapter with seal ring is part of the breathing system. This Drägerwerk AG & Co KGaA, Lübeck, Germany Draeger Medical, Inc., Telford, PA, USA Vol.:(0123456789) 1 3 Journal of Clinical Monitoring and Computing Fig. 1 Extract from the Instructions for Use (CLIC absorber 800+/CLIC adapter): steps to exchange the CLIC absorber Fig. 3 Gas flow inside the Apollo breathing system, with proper posi- Fig. 2 Missing seal ring on the left side CLIC adapter tioned seal ring procedure shall assure that the breathing system is complete To assist our users and further reduce the likelihood of prior to operation. such use failures, Dräger made the following changes to sig- If the inner seal ring of the CLIC adapter is missing, as nificantly reduce the opportunity of this finding reoccurring: in the described case, the integrated gas measurement of the device ensures that the high inspiratory CO concentra- In the middle of 2008, Dräger migrated from the “old tions are detected and alarmed immediately. One cause for style” CLIC adapter to the “new style” CLIC adapter. this event may be that there is an internal leak or fault in the The significance of this migration is that the “new style” breathing system, as stated in the Instructions for Use of the CLIC adapter is to be replaced every 4 years, and no Dräger Apollo© Workstation, in the chapter “Fault-Cause- longer requires preventive maintenance. This eliminates Remedy”. A remedy to this cause is to replace the breathing the concern of the CLIC adapter being reassembled system which includes the CLIC adapter. 1 3 Journal of Clinical Monitoring and Computing have already migrated to the new design (as long as the 4 year replacement strategy defined by Dräger is being followed). For customers with Apollos including the CLIC option shipped prior to June of 2008 (and have yet to migrate to the “new style” CLIC adapter), a migra- tion could be considered. Again, we have received very few reports similar to this submission, but this migration option is available. The part number for the “new style” CLIC adapter is MX50090. While Dräger did not have the opportunity to inspect this Fig. 4 Schematic of the breathing system with missing seal ring: machine, based on the images provided, the case described pneumatic short cut inside the CLIC absorber which leads to no CO by Nikman et  al. shows a CLIC adapter manufactured removal between mid 2008 and end of 2013. As a summary we very much thank the authors Nikman incorrectly by the institution following preventive main- et al. to bring this case to the attention of the readers of tenance. this journal. The submission provided an overview how the At the end of 2013, Dräger further improved the design device’s integrated gas measurement ensured that the high of CLIC adapter to include adhesive to this seal. This inspiratory CO concentrations were detected and alarmed new design eliminates the opportunity for the scenario immediately. In addition, the submission highlighted the described by the author to occur via high forces or during importance of proper training and servicing according to cleaning. What this means is: the Instructions for Use. Open Access This article is distributed under the terms of the Crea- All Apollos shipped with the CLIC option after end tive Commons Attribution 4.0 International License (http://creat iveco of 2013 include this new design which includes the mmons.or g/licenses/b y/4.0/), which permits unrestricted use, distribu- new adhesive to this seal. tion, and reproduction in any medium, provided you give appropriate • Apollos shipped with the CLIC option between 2008 credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. and 2013 with the “new style” CLIC adapter should 1 3

Journal

Journal of Clinical Monitoring and ComputingSpringer Journals

Published: May 31, 2018

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