TUBING SET
Report
- Report Number
- 8010762-2025-0000119
- Event Type
- Death
- Date Received
- March 18, 2025
- Date of Event
- February 16, 2025
- Report Date
- April 1, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- UDI-DI
- 04058863080383
- PMA / PMN Number
- K112360
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE EVENT OCCURRED IN THE USA DURING PRIMING. FOLLOWING WAS REPORTED IN THE IMPORTER REPORT 1600820000-2025-8020. CVL (CARDIOVASCULAR LAB) STEMI (ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION) TEAM CALLED IN TO HAVE ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) CANNULATION AND INITIATION STARTED ON A CCU (CORONARY CARE UNIT) PATIENT. THE PATIENT WAS BROUGHT DOWN TO CATHETER LAB AND ECLS (EXTRACORPOREAL LIFE SUPPORT) TEAM STARTED SETTING UP ECMO DEVICE WHILE THE PROVIDER AND CVL STAFF BEGAN GETTING ACCESSES FOR SHEATH CANNULATION. SHEATH CANNULATION WAS COMPLETED. THE ECMO DEVICE WAS FILLING AND CIRCULATING FOAM AND WAS UNABLE TO BE CONNECTED TO PATIENT. ECLS TEAM NEEDED TO GO SET UP A NEW KIT AND PUMP UPSTAIRS. THE PATIENT WAS CONNECTED TO A NEW ECMO SET 1 HOUR AFTER CATHETER LAB TEAM ACHIEVED CANNULATION OF BILATERAL FEMORAL AND RETROGRADE ACCESS. ADDITIONAL 15 MINUTES FROM THE TIME THE PATIENT WAS CONNECTED TO THE PUMP TO THE PATIENT RECEIVING OXYGENATED BLOOD WERE NEEDED. ADDITIONAL INFORMATION WAS RECEIVED ON 2025-03-18/19 THAT THE PATIENT PASSED AWAY 24 HOURS AFTER HE WAS ON THE SECOND HLS SET CONNECTED DUE TO THE FAMILY DECIDED TO GIVE UP TREATMENT. THE PATIENT WAS A STEMI THAT CODED MULTIPLE TIMES. THE PHYSICIAN INITIATED THE ECMO THERAPY AFTER THE PATIENT WAS REVIVED FROM MULTIPLE CODES AND WAS UNSTABLE. IT WAS STATED THAT THE FIRST USED SET WAS NEVER CONNECTED TO THE PATIENT AND THE CUSTOMER STATED THAT THE MOST PROBABLE ROOT CAUSE WITH THE FIRST HLS SET WAS AN IN-EXPERIENCED NEW ECMO- SPECIALIST WHO PRIMED THE CIRCUIT AND DID NOT DE AIR THE CIRCUIT CORRECTLY CAUSING THE FOAM. THE SECOND HLS SET WHICH WAS THAN USED ON THE PATIENT HAD NO FAILURE. THE PATIENT PASSED AWAY ON (B)(6) 2025. BOTH SETS ARE NOT AVAILABLE FOR INVESTIGATION, AS THEY WERE DISCARDED BY THE CUSTOMER. FURTHER THE CUSTOMER CONFIRMED THAT THE PATIENT PASSED AWAY FROM HIS PRE-EXISTING CONDITIONS AND NOT FROM THE FAILURE OF THE FIRST HLS SET, WHICH CAUSED A DELAY IN TREATMENT. A MEDICAL REVIEW WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON 2025-03-31 WITH FOLLOWING CONCLUSION: "ACCORDING TO THE COMPLAINT NARRATIVE, A STEMI (ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION)TEAM WAS CALLED TO INITIATE ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) CANNULATION FOR A PATIENT IN THE CORONARY CARE UNIT (CCU). THE PATIENT WAS TRANSFERRED TO THE CATH LAB, WHERE THE EXTRACORPOREAL LIFE SUPPORT (ECLS) TEAM SET UP THE ECMO DEVICE WHILE THE PROVIDER AND CVL STAFF PERFORMED VASCULAR ACCESS FOR SHEATH CANNULATION. CANNULATION OF BILATERAL FEMORAL AND RETROGRADE ACCESS WAS COMPLETED SUCCESSFULLY. DURING PRIMING, THE ECMO CIRCUIT EXHIBITED EXCESSIVE FOAM, PREVENTING PATIENT CONNECTION AND DELAYING EXTRACORPOREAL PERFUSION. WITH NO BACKUP SET ON-SITE, THE ECLS TEAM RETRIEVED A REPLACEMENT CIRCUIT AND PUMP FROM ANOTHER LOCATION, DELAYING TREATMENT. THE PATIENT WAS CONNECTED TO THE NEW ECMO SET ONE HOUR AFTER CANNULATION, WITH AN ADDITIONAL 15-MINUTE DELAY BEFORE OXYGENATED BLOOD CIRCULATION BEGAN. THE INTENDED PROCEDURE WAS TO PRIME THE ECMO CIRCUIT WITHOUT VISIBLE BUBBLES FOR IMMEDIATE PATIENT CONNECTION AND SUPPORT. HOWEVER, FOAMING COMPROMISED THE CIRCUIT, DELAYING PATIENT CONNECTION BY OVER AN HOUR. THE LACK OF A BACKUP SET FURTHER EXTENDED THIS DELAY, POTENTIALLY IMPACTING PATIENT STABILITY. A STUDY PUBLISHED IN ACS OMEGA EXAMINED THE STABILITY OF LIQUID FILMS FORMED BY BUBBLES IN BOVINE SERUM ALBUMIN SOLUTIONS. THE RESEARCH HIGHLIGHTED THAT THE AMPHIPATHIC CHARACTERISTICS OF ALBUMIN CONTRIBUTE TO THE FORMATION AND STABILIZATION OF FOAM FILMS, EMPHASIZING THE ROLE OF ALBUMIN AT THE AIR-LIQUID INTERFACE. THIS SUGGESTS THAT THE EXCESSIVE FOAM OBSERVED DURING PRIMING MAY HAVE BEEN DUE TO THE DIRECT INCLUSION OF ALBUMIN INTO THE PRIMING SOLUTION, LEADING TO INCREASED BUBBLE FORMATION. THE PATIENT, A STEMI CASE, HAD SUFFERED MULTIPLE CARDIAC ARRESTS BEFORE ECMO INITIATION. AFTER RESUSCITATION AND STABILIZATION, THE PHYSICIAN INITIATED CARDIOHELP THERAPY DUE TO CONTINUED INSTABILITY. THE PATIENT¿S FAMILY OPTED TO DISCONTINUE SUPPORT AFTER 24 HOURS. THE ATTENDING PHYSICIAN CONFIRMED THAT THE PATIENT¿S DEATH RESULTED FROM PRE-EXISTING CARDIAC CONDITIONS RATHER THAN EQUIPMENT FAILURE. ADDITIONALLY, FEEDBACK FROM THE ECMO MANAGER SUGGESTED THAT THE INITIAL CIRCUIT PRIMING ISSUE MAY HAVE RESULTED FROM IMPROPER DE-AIRING. FURTHERMORE, IT WAS CONFIRMED THAT THE PATIENT EXPIRED DUE TO PRE-EXISTING CONDITIONS RATHER THAN ANY FAILURE OF THE ECMO SYSTEM. IN CONCLUSION, THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION IN THIS INCIDENT. HOWEVER, THE DELAY IN INITIATING EXTRACORPOREAL PERFUSION DUE TO INITIAL PRIMING ISSUES MAY HAVE CONTRIBUTED TO THE OVERALL PATIENT OUTCOME. THE EXCESSIVE FOAM OBSERVED DURING PRIMING, WHICH PREVENTED IMMEDIATE PATIENT CONNECTION, MAY HAVE BEEN INFLUENCED BY THE INCLUSION OF ALBUMIN IN THE PRIMING SOLUTION. RESEARCH HAS SHOWN THAT ALBUMIN'S AMPHIPATHIC PROPERTIES CONTRIBUTE TO FOAM STABILIZATION, POTENTIALLY LEADING TO INCREASED BUBBLE FORMATION. AS BOTH ECMO SETS INVOLVED IN THIS CASE WERE DISCARDED BY THE CUSTOMER, NO FURTHER INVESTIGATION CAN BE CONDUCTED, AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED." ACCORDING TO THE INSTRUCTION OF USE OF THE HLS SET (CHAPTER "SAFETY INSTRUCTIONS FOR THE OXYGENATOR") IT IS STATED THAT THE DE-AIRING MEMBRANE MUST BE OPEN THROUGHOUT PRIMING TO ENSURE SAFE DE-AIRING OF THE OXYGENATOR AND TO ENSURE THAT THE DE-AIRING MEMBRANE OF THE OXYGENATOR IS CLOSED WITH THE YELLOW PROTECTIVE CAP DURING OPERATION. THE FLOW/BUBBLE SENSOR MUST ALWAYS BE AFFIXED ON THE ARTERIAL SIDE OF THE SET IF YOU ARE USING THE CARDIOHELP-I. WITH AN ACTIVATED INTERVENTION, THE DETECTION OF BUBBLES BY THE FLOW/BUBBLE SENSOR TRIGGERS A PUMP STOP. IN CHAPTER "PRIMING THE SYSTEM" IT IS MENTIONED THAT PRE-PRIMING CAN CAUSE AIR BUBBLES TO FORM IN THE SYSTEM. REFERRING TO THE CHAPTER "START PERFUSION" THE CUSTOMER SHOULD ENSURE THAT THE TUBE SYSTEM HAS BEEN COMPLETELY DE-AIRED BEFORE STARTING THE PERFUSION. IN ORDER TO AVOID REOCCURRENCE OF THE REPORTED FAILURE, THE CUSTOMER WILL BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER PRIMING THE SYSTEM AND TO RE-TRAIN THE NEW MEDICAL STUFF. THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED ON 2025-03-31. ACCORDING TO THE FINAL TEST RESULTS, THE PRODUCT PASSED THE TESTS AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE REVIEW OF SCRAP, REWORK, ENHANCEMENTS AND DESIGN CHANGES WERE REVIEWED AN NO ABNORMALITIES IN REGARDS TO THE REPORTED FAILURE WERE FOUND. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED FOR THE REVIEWED TIME PERIOD. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARDS TO THE REPORTED FAILURE. BASED ON THE RESULTS THE REPORTED FAILURE "AIR IN PRODUCT" COULD BE CONFIRMED, BUT WAS NOT A PRODUCT RELATED MALFUNCTION. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.
ADDITIONAL INFORMATION WAS RECEIVED ON 2025-03-18/19 THAT THE PATIENT PASSED AWAY 24 HOURS AFTER ON THE SECOND HLS SET CONNECTED DUE TO THE FAMILY DECIDED TO GAVE UP TREATMENT. THE PATIENT WAS A STEMI THAT CODED MULTIPLE TIMES. THE PHYSICIAN INITIATED THE ECMO THERAPY AFTER THE PATIENT WAS REVIVED FROM MULTIPLE CODES AND WAS UNSTABLE. IT WAS STATED THAT THE FIRST USED SET WAS NEVER CONNECTED TO THE PATIENT AND THE CUSTOMER STATED THAT THE MOST PROBABLE ROOT CAUSE WITH THE FIRST HLS SET WAS AN IN-EXPERIENCED NEW ECMO- SPECIALIST WHO PRIMED THE CIRCUIT AND DID NOT DE AIR THE CIRCUIT CORRECTLY CAUSING THE FOAM. THE SECOND HLS SET WHICH WAS THAN USED ON THE PATIENT HAD NO FAILURE. THE PATIENT PASSED AWAY ON (B)(6) 2025. BOTH SETS ARE NOT AVAILABLE FOR INVESTIGATION, AS THEY WERE DISCARDED BY THE CUSTOMER. FURTHER THE CUSTOMER CONFIRMED THAT THE PATIENT PASSED AWAY FROM HIS PRE-EXISTING CONDITIONS AND NOT DUE TO THE EVENT WITH THE FIRST HLS SET, WHICH CAUSED A DELAY IN TREATMENT. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THE LOT NUMBER OF THE AFFECTED SET WAS NOT PROVIDED. THEREFORE, IT IS NOT POSSIBLE TO IDENTIFY THE SET LOT NUMBER OF THE DEVICE IN QUESTION AND THEREFORE ITS UDI NUMBER.
COMPLAINT ID# (B)(4).
COMPLAINT ID# (B)(4).
THE EVENT OCCURRED IN THE USA DURING PRIMING. FOLLOWING WAS REPORTED IN THE IMPORTER REPORT # (B)(4). CVL (CARDIOVASCULAR LAB) STEMI (ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION) TEAM CALLED IN TO HAVE ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) CANNULATION AND INITIATION STARTED ON A CCU (CORONARY CARE UNIT) PATIENT. THE PATIENT WAS BROUGHT DOWN TO CATHETER LAB AND ECLS (EXTRACORPOREAL LIFE SUPPORT) TEAM STARTED SETTING UP ECMO DEVICE WHILE THE PROVIDER AND CVL STAFF BEGAN GETTING ACCESSES FOR SHEATH CANNULATION. SHEATH CANNULATION WAS COMPLETED. THE ECMO DEVICE WAS FILLING AND CIRCULATING FOAM AND WAS UNABLE TO BE CONNECTED TO PATIENT. ECLS TEAM NEEDED TO GO SET UP A NEW KIT AND PUMP UPSTAIRS. THE PATIENT WAS CONNECTED TO A NEW ECMO SET 1 HOUR AFTER CATHETER LAB TEAM ACHIEVED CANNULATION OF BILATERAL FEMORAL AND RETROGRADE ACCESS. ADDITIONAL 15 MINUTES FROM THE TIME THE PATIENT WAS CONNECTED TO THE PUMP TO THE PATIENT RECEIVING OXYGENATED BLOOD WERE NEEDED. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE DELAY IN TREATMENT OF THE PATIENT, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 991969 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS SET | 3000400405 | 04058863080383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Death |