TUBING SET
Report
- Report Number
- 8010762-2025-0000193
- Event Type
- Death
- Date Received
- April 28, 2025
- Date of Event
- April 16, 2025
- Report Date
- July 2, 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
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE AFFECTED HLS SET WAS REQUESTED FOR FURTHER INVESTIGATION AND WAS INVESTIGATED IN THE GETINGE LABORATORY ON 2025-06-12 WITH THE FOLLOWING CONCLUSION: "THE REPORTED FAILURE COULD NOT BE REPRODUCED AND NOT BE CONFIRMED DURING THE INVESTIGATION. THE HLS SET SHOWED NO DAMAGES AND NO ABNORMALITIES WERE DETECTED DURING TESTING." THE INVOLVED CARDIOHELP DEVICE IS INVESTIGATED WITHIN COMPLAINT #(B)(4) AND IS REPORTED UNDER MFG REPORT NUMBER #8010762-2025-0000194. A MEDICAL REVIEW WAS REQUESTED BY GETINGE MEDICAL AFFAIRS. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE GERMAN 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.
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE GERMAN 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 GERMANY. IT WAS REPORTED THAT DURING PATIENT TREATMENT ON (B)(6) 2025, THE INVOLVED CARDIOHELP DEVICE WAS NOISY. THUS, THE CARDIOHELP DEVICE WAS REPLACED. ON (B)(6) 2025 THERE WAS AN INCREASE IN THE HEMOLYSIS PARAMETERS. AFTER THIS NOTICE, THE HLS SET WAS REPLACED. ON (B)(6) 2025 THE CUSTOMER CONFIRMED THAT THE PATIENT PASSED AWAY DUE TO A SEPTIC SHOCK. DUE TO DEVICE EXCHANGES AND AS THE INVOLVED PATIENT PASSED AWAY A REPORT IS REQUIRED. THE AFFECTED HLS SET WAS INVESTIGATED IN THE GETINGE LABORATORY ON (B)(6) 2025 WITH THE FOLLOWING CONCLUSION: "THE REPORTED FAILURE COULD NOT BE REPRODUCED AND NOT BE CONFIRMED DURING THE INVESTIGATION. THE HLS SET SHOWED NO DAMAGES, AND NO ABNORMALITIES WERE DETECTED DURING TESTING. THUS, NO EXACT ROOT CAUSE COULD BE DETERMINED." THE INVOLVED CARDIOHELP DEVICE IS INVESTIGATED WITHIN COMPLAINT # (B)(4) AND IS REPORTED UNDER MFG REPORT NUMBER # 8010762-2025-0000194. ON 2025-05-27, THE INFORMATION WAS RECEIVED THAT THE AFFECTED CARDIOHELP DEVICE WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN AND RECEIVED PREVENTIVE MAINTENANCE. NO ABNORMALITIES WERE FOUND WITH THE CARDIOHELP DEVICE. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. A MEDICAL REVIEW WAS PERFORMED ON 2025-06-20 WITH FOLLOWING CONCLUSION: "THE REPORTED INCIDENT INVOLVES A 46-YEAR-OLD MALE PATIENT (184 CM, 180 KG) UNDERGOING VVECMO THERAPY SUPPORTED CH-I AND HLS-SET. ON (B)(6) 2025, A MECHANICAL NOISE WAS NOTED DURING ONGOING THERAPY. AT THE TIME OF INITIAL OBSERVATION, NO DETERIORATION IN DEVICE PERFORMANCE WAS DETECTED. ECMO SUPPORT WAS TECHNICALLY STABLE, WITH CONSISTENT FLOW PARAMETERS (5.0 - 5.3 L/MIN), PUMP ROTATIONAL SPEEDS (3,400 - 4,100 RPM), AND DELTA P (35 - 38 MMHG). VENOUS DRAINAGE PRESSURES WERE WITHIN ACCEPTABLE NEGATIVE RANGES (-63 TO -78 MMHG). DUE TO PERSISTING ACOUSTIC ANOMALIES, THE CH-I WAS ELECTIVELY EXCHANGED ON (B)(6). NO CLINICAL OR TECHNICAL CHANGE RESULTED FROM THE INTERVENTION. SUBSEQUENTLY, A SUDDEN AND PRONOUNCED INCREASE IN HEMOLYSIS PARAMETERS WAS RECORDED, INCLUDING AN ELEVATION IN PLASMA-FREE HEMOGLOBIN (FHB) FROM 2 MG/DL TO 114 MG/DL, LDH FROM 400 TO 1,300 U/L, AND TOTAL BILIRUBIN FROM 1 TO 5 MG/DL. DESPITE THESE BIOCHEMICAL FINDINGS, NO ABNORMAL TRENDS IN ECMO FLOW OR PRESSURES WERE DETECTED. THAT SAID, THE LABORATORY RESULTS PROVIDED BY THE CUSTOMER ARE SUGGESTIVE OF HEMOLYSIS AND APPEAR TO CONFIRM THE ASSESSMENT OF THE ATTENDING CLINICIAN PRE-EXCHANGE. TECHNICAL EVALUATIONS OF BOTH THE CARDIOHELP CONSOLE AND THE RETURNED HLS-SET DID NOT IDENTIFY ANY MALFUNCTION OR PERFORMANCE DEVIATION. FUNCTIONAL, LEAKAGE, AND CALIBRATION CHECKS WERE COMPLETED ACCORDING TO FACTORY SPECIFICATIONS, AND NO DAMAGE, OCCLUSION, OR THROMBOSIS WAS EVIDENT. VISUAL INSPECTION OF THE HLS-SET REVEALED RESIDUAL BLOOD IN THE PUMP MODULE BUT NO IDENTIFIABLE MECHANICAL DEFECT. ALL PRESSURE AND FLOW PARAMETERS REMAINED WITHIN SPECIFICATION DURING LABORATORY TESTING. FOLLOWING THE ONSET OF HEMOLYSIS, CLINICAL MANAGEMENT INCLUDED THE REPLACEMENT OF THE HLS-SET. POST-EXCHANGE, A RAPID DECLINE IN HEMOLYSIS MARKERS WAS OBSERVED: FHB DECREASED FROM 114 TO 3 MG/DL, BILIRUBIN FROM 5 TO 3 MG/DL, AND HAPTOGLOBIN INCREASED FROM 0.1 TO 0.5 G/L. THIS IMMEDIATE BIOCHEMICAL NORMALIZATION APPEARS TO SUPPORT A TEMPORAL AND POTENTIALLY CAUSAL ASSOCIATION BETWEEN THE HLS-SET AND THE HEMOLYTIC REPORT. ALTHOUGH NO VISIBLE OR MECHANICAL CAUSE WAS IDENTIFIED DURING TECHNICAL ANALYSIS, THE CLINICAL FINDINGS SUGGEST THE POSSIBILITY OF BIOLOGICALLY MEDIATED OXYGENATOR IMPAIRMENT. THIS MAY INCLUDE MICRO THROMBOTIC DEPOSITION, FIBRIN ACCUMULATION, OR PROTEIN ADHESION ON THE MEMBRANE SURFACE, NONE OF WHICH ARE CONSISTENTLY DETECTABLE VIA ROUTINE POST-USE INSPECTION. SUCH MECHANISMS HAVE BEEN DESCRIBED IN PUBLISHED LITERATURE AS POTENTIAL CAUSES OF HEMOLYSIS DURING VV-ECMO, EVEN IN THE ABSENCE OF ELEVATED PRESSURE GRADIENTS OR DEVICE MALFUNCTION. THE PATIENT ULTIMATELY EXPIRED DUE TO SEPTIC SHOCK. CLINICAL INDICATORS, INCLUDING RISING PTT VALUES (46.4 TO 68.3 S), POINT TOWARD SYSTEMIC INFLAMMATORY PROGRESSION (4, 5). NO SIGNS OF OVERT DIC OR BLEEDING WERE DOCUMENTED PRIOR TO EXPIRATION. BASED ON THE CLINICAL TIMELINE, THE HEMOLYTIC EVENT PRECEDED THE WORSENING SEPSIS, AND WHILE IT MAY HAVE CONTRIBUTED TO CLINICAL DETERIORATION, IT WAS (REPORTEDLY) NOT THE DIRECT CAUSE OF DEATH. THEREFORE, A CAUSAL RELATIONSHIP BETWEEN THE PRODUCT USE AND THE PATIENT OUTCOME CANNOT BE ESTABLISHED." THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED ON 2025-06-13. ACCORDING TO THE FINAL TEST RESULTS, THE MODULE WITH LOT # 3000446977 AND UDI # (B)(4) PASSED THE TESTS AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES ARE UNLIKELY. 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 PRODUCT AND FAILURE. BASED ON THE RESULTS, THE REPORTED EVENT "INCREASE IN THE HEMOLYSIS PARAMETERS" WAS NOT RELATED TO A PRODUCT MALFUNCTION. THIS COMPLAINT WAS FOUND AS A SINGLE EVENT IN THE DATABASE OF CUSTOMER COMPLAINTS FOR THE INDICATED TIMEFRAME. 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. NOTE: THIS EVENT OCCURRED ON THE GERMAN 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.
COMPLAINT ID #(B)(4).
THE EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT DURING PATIENT TREATMENT ON (B)(6) 2025 THE INVOLVED CARDIOHELP DEVICE WAS NOISY. THUS, THE CARDIOHELP DEVICE WAS REPLACED. ON (B)(6) 2025 THERE WAS AN INCREASE IN THE HEMOLYSIS PARAMETERS. AFTER THIS NOTICE, THE HLS SET WAS REPLACED. ON (B)(6) 2025 THE CUSTOMER CONFIRMED THAT THE PATIENT PASSED AWAY DUE TO A SEPTIC SHOCK. THE AFFECTED CARDIOHELP DEVICE WILL BE INVESTIGATED IN COMPLAINT # (B)(4). HLS SET COMPLAINT ID # (B)(4).
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1757696 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS SET | 3000452355 | 04058863005744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Male | Death |