TUBING SET
Report
- Report Number
- 8010762-2025-0000123
- Event Type
- Death
- Date Received
- March 19, 2025
- Date of Event
- March 16, 2025
- Report Date
- June 6, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- UDI-DI
- 04058863005744
- PMA / PMN Number
- K112360
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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.
THE PATIENT LOST 1000ML OF BLOOD. THE PATIENT UNDERWENT A TWO MINUTE CARDIOPULMONARY RESUSCITATION DURING THE ECMO CIRCUIT EXCHANGE DUE TO SEVERE CARDIAC DYSFUNCTION SUBSEQUENT TO EXTENSIVE MYOCARDIAL INFARCTION. NEW INFORMATION WAS RECEIVED ON 2025-04-01 THAT THE OUTCOME OF THE PATIENT WAS DEATH DUE TO LATE COMPLICATIONS, DAYS AFTER WEANING OFF FROM THE ECMO. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE CZECHIA MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "HLS SET¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K112360. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR HLS SET WITH CATALOG NUMBER 701069073.
THE EVENT OCCURRED IN CZECHIA DURING TREATMENT. IT WAS REPORTED THAT THERE WAS A BLOOD LEAK DIRECTLY FROM THE OXYGENATOR. THE CUSTOMER MANUALLY COMPRESSED THE LEAKAGE POINT AND REPLACED THE HLS SET. THE PATIENT HAD TO BE RESUSCITATED AND SURVIVED. A BLOOD TRANSFUSION WAS REQUIRED. AS THE PATIENT NEEDED A BLOOD TRANSFUSION, REQUIRED RESUSCITATION AND LATER PASSED AWAY, A REPORT IS REQUIRED. NEW INFORMATION WAS RECEIVED THAT THE PATIENT LOST 1000ML OF BLOOD. THE PATIENT UNDERWENT A TWO MINUTE CARDIOPULMONARY RESUSCITATION DURING THE ECMO CIRCUIT EXCHANGE DUE TO SEVERE CARDIAC DYSFUNCTION SUBSEQUENT TO EXTENSIVE MYOCARDIAL INFARCTION. NEW INFORMATION WAS RECEIVED ON 2025-04-01 THAT THE PATIENT PASSED DUE TO LATE COMPLICATIONS, DAYS AFTER WEANING FROM THE ECMO. THE AFFECTED PRODUCT WAS INVESTIGATED BY THE GETINGE LABORATORY ON 2025-05-15. THE REPORTED FAILURE COULD BE CONFIRMED, BUT THE EXACT ROOT CAUSE COULD NOT BE DETERMINED BUT MOST PROBABLY RELATED TO A LEAKAGE IN THE INTERNAL PRESSURE SENSOR. A MEDICAL REVIEW WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON 2025-05-28 WITH FOLLOWING CONCLUSION: "ACCORDING TO THE COMPLAINT NARRATIVE, THE INCIDENT INVOLVES A 54-YEAR-OLD MALE PATIENT ON VA-ECMO SUPPORT WITH A CARDIOHELP SYSTEM AND HLS SET ADVANCED 7.0, WHO EXPERIENCED A SUDDEN BLOOD LEAK FROM THE OXYGENATOR APPROXIMATELY THREE HOURS AFTER THERAPY INITIATION. THIS LED TO A SIGNIFICANT DROP IN ARTERIAL PRESSURE AND REQUIRED URGENT CIRCUIT REPLACEMENT. MANUAL COMPRESSION WAS APPLIED TO THE LEAK SITE, AND THE HLS SET WAS REPLACED. THE PATIENT UNDERWENT TWO MINUTES OF CPR DUE TO SEVERE CARDIAC DYSFUNCTION AND REQUIRED BLOOD TRANSFUSION. THE PATIENT INITIALLY SURVIVED BUT LATER EXPIRED FROM COMPLICATIONS AFTER ECMO WEANING. INVESTIGATION CONFIRMED THE COMPLAINT. BLOOD RESIDUES AND LEAKAGE WERE LOCALIZED TO THE INTERNAL PRESSURE SENSOR AREA. THE HLS SET WAS INSPECTED PRIOR TO USE WITH NO VISIBLE ISSUES, AND NO LEAKS WERE DETECTED DURING PRIMING. THE LEAK INVOLVED BLOOD ONLY. IMMEDIATE CLINICAL RESPONSE PREVENTED FURTHER HARM. IT IS IMPORTANT TO NOTE THAT DURING THE TECHNICAL INVESTIGATION, ONLY DROPLET FORMATION WAS OBSERVED AT THE BLOOD INLET COVER AS EVIDENCE OF LEAKAGE. HOWEVER, THE COMPLAINT NARRATIVE REPORTS AN ESTIMATED TOTAL BLOOD LOSS OF APPROXIMATELY 1000 ML, WITHOUT SPECIFYING THE EXACT TIME FRAME OVER WHICH THIS LOSS OCCURRED. THIS DISCREPANCY HIGHLIGHTS A GAP IN THE INFORMATION REGARDING THE PROGRESSION AND SEVERITY OF THE LEAKAGE. A PRODUCT MALFUNCTION WAS CONFIRMED THROUGH THE INVESTIGATION, SPECIFICALLY RELATED TO DEFECTS IN THE INTERNAL PRESSURE SENSOR. ACCORDING TO THE CUSTOMER¿S STATEMENT, ¿THE PATIENT INITIALLY SURVIVED BUT LATER EXPIRED FROM COMPLICATIONS AFTER ECMO WEANING.¿ THIS SUGGESTS THAT THE PATIENT¿S EVENTUAL EXPIRATION WAS LIKELY NOT DIRECTLY CAUSED BY THE HLS MALFUNCTION. NONETHELESS, THE URGENT NEED TO REPLACE THE HLS SET AND THE RESUSCITATION EFFORTS DESCRIBED DURING THIS PERIOD UNDERSCORE THE POTENTIAL FOR SERIOUS HARM HAD THE INTERVENTION BEEN DELAYED OR UNSUCCESSFUL. IN SUMMARY, WHILE THE HLS MALFUNCTION WAS VERIFIED BY INTERNAL GETINGE TESTING. MOREOVER, THE REPORTED EVENT LIKELY CONTRIBUTED TO THE CRITICAL CLINICAL OCCURRENCE, SPECIFICALLY CPR AND BLOOD TRANSFUSION. THE PATIENT¿S EXPIRATION APPEARS TO BE UNRELATED TO THE DEVICE FAILURE ITSELF, HAVING OCCURRED AN UNDEFINED PERIOD AFTER THE EVENT. IT IS ASSUMED THAT THE LOSS OF EXTRACORPOREAL SUPPORT (I.E., EXPERIENCED DURING PRODUCT EXCHANGE) LIKELY PRECIPITATED CPR. FURTHER, THE LOSS OF BLOOD VOLUME APPEARS TO BE DIRECTLY RELATED TO THE ADMINISTRATION OF BLOOD PRODUCTS." ACCORDING TO THE INSTRUCTION FOR USE (IFU, HLS SET ADVANCED 6.0/7.0, HIT SET ADVANCED 5.0/7.0) IT IS STATED IN CHAPTER ¿SAFETY INSTRUCTIONS FOR CENTRIFUGAL PUMP¿ THAT LEAKS OR SCRATCHING NOISES IN THE CENTRIFUGAL PUMP CAN BE A SIGN THAT IT IS MALFUNCTIONING. MALFUNCTIONING CAN LEAD TO INADEQUATE PATIENT SUPPORT. FURTHERMORE, IT IS MENTIONED TO ALWAYS KEEP A REPLACEMENT HLS SET FOR THOSE SITUATIONS. IN CHAPTER ¿PRIMING THE SYSTEM¿ IT IS WRITTEN NOT TO PRE-PRIME THE CIRCUIT TOO EARLY AS THIS COULD LEAD TO LEAKS AND TO NOT USE A DEVICE IF THERE ARE ANY LEAKS. THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED ON 2025-06-02. 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 AND 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 "LEAKAGE ON THE OXYGENATOR" COULD BE CONFIRMED. THE PATIENT¿S EXPIRATION APPEARS TO BE UNRELATED TO THE DEVICE FAILURE ITSELF, HAVING OCCURRED AN UNDEFINED PERIOD AFTER THE EVENT. 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. THIS COMPLAINT WAS FOUND IN THE DATABASE OF CUSTOMER COMPLAINTS FOR THE HLS SET WITH ARTICLE (B)(4) AS A SINGLE EVENT (TIMEFRAME FROM 2024-03-17 TILL 2025-03-17). ACCORDING TO THE RISK REVIEW THE REPORTED FAILURE IS BELOW THE ACCEPTANCE THRESHOLD ACCORDING TO THE RISK MANAGEMENT PLAN OF THE HLS SET. 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.
THE EVENT OCCURRED IN CZECHIA DURING TREATMENT. IT WAS REPORTED THAT THERE WAS A BLOOD LEAK DIRECTLY FROM THE OXYGENATOR. THE CUSTOMER MANUALLY COMPRESSED THE LEAKAGE POINT AND REPLACED THE HLS SET. THE PATIENT HAD TO BE RESUSCITATED AND SURVIVED. A BLOOD TRANSFUSION WAS REQUIRED. AS THE PATIENT NEEDED A BLOOD TRANSFUSION AND REQUIRED RESUSCITATION, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).
COMPLAINT ID# (B)(4).
COMPLAINT ID (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1209733 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS SET | 3000439760 | 04058863005744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Life Threatening| D| R |