HLS CANNULAE & PIK
Report
- Report Number
- 8010762-2025-0000146
- Event Type
- Death
- Date Received
- March 28, 2025
- Date of Event
- March 17, 2025
- Report Date
- May 13, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DWF
- UDI-DI
- 04037691589657
- PMA / PMN Number
- K102532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.
NEW INFORMATION WAS RECEIVED ON 2025-04-17 AS THE PATIENT HAS EXPIRED DUE TO SEVERE CARDIOGENIC SHOCK. THE REPORTED FAILURE 'CRACK ON HLS CANNULAE CONNECTOR' DID NOT AFFECT THE PATIENT TREATMENT DIRECTLY. HOWEVER, THE FAMILY MEMBERS OF PATIENT VOLUNTARILY GAVE UP FROM TREATMENT. FURTHER, CUSTOMER CONFIRMS THAT THE BOTH PRODUCTS WERE NOT CHANGED DURING TREATMENT 'BE-PAL 1723 AND PLS 2050'. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.
A 57-YEAR-OLD PATIENT UNDERWENT VA-ECMO ON (B)(6) 2025, DUE TO MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. SHORTLY AFTER ECMO INITIATION, MINOR BLOOD SEEPAGE WAS OBSERVED AT THE ARTERIAL CANNULA CONNECTOR. NO ISSUES WERE IDENTIFIED DURING PRE-USE INSPECTION. THE PATIENT¿S CONDITION DETERIORATED, AND TREATMENT WAS DISCONTINUED AT THE FAMILY'S REQUEST. THE PATIENT SUBSEQUENTLY EXPIRED. IT WAS LATER CONFIRMED BY THE SSU THAT THE BE-PAL 1723 AND PLS 2050 COMPONENTS REMAINED UNCHANGED THROUGHOUT THE TREATMENT. SAMPLE INVESTIGATION COULD NOT BE PERFORMED AS THE PRODUCT WAS DISCARDED BY CUSTOMER. HOWEVER, PHOTOGRAPHICAL EVIDENCE WAS RECEIVED FROM CUSTOMER THAT SHOWS THE CRACK CLEARLY, BASED ON THIS THE COMPLAINT COULD BE CONFIRMED. GETINGE MEDICAL AFFAIRS CONDUCTED A MEDICAL REVIEW ON 2025-05-09. WHILE THE EXACT CAUSE OF THE LEAKAGE REMAINS UNCLEAR DUE TO LIMITED EVIDENCE AND THE ABSENCE OF THE INVOLVED COMPONENTS FOR ANALYSIS, IT IS WORTH NOTING THAT HOSE TIES WERE NOT USED TO SECURE THE TUBE CONNECTIONS, AS RECOMMENDED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU ADVISES: DETACHMENT OF UNSECURED TUBE CONNECTIONS CAN LEAD TO BLOOD LOSS AND AIR EMBOLISMS IN THE PATIENT. CHECK THAT TUBE CONNECTIONS ARE CORRECTLY AND SECURELY FASTENED. SECURE ALL TUBE CONNECTIONS IN THE TUBE SYSTEM WITH HOSE TIES. CONSIDERING THAT A LIMB PERFUSION LINE WAS CONNECTED, AND THE LEAK OCCURRED SHORTLY AFTER ECMO INITIATION, ONE POTENTIAL ROOT CAUSE COULD BE MECHANICAL STRESS AT THE CONNECTION POINT, POSSIBLY DUE TO HANDLING OR OVER-TIGHTENING OF THE LUER LOCK. OTHER POTENTIAL ALTERNATIVE ROOT CAUSES MAY INCLUDE INADVERTENT MECHANICAL STRESS MICROFRACTURES FROM MATERIAL FATIGUE OR AN UNDETECTED MANUFACTURING DEFECT THAT BECAME EVIDENT UNDER OPERATIONAL STRESS. HOWEVER, AS THE CANNULA AND CONNECTOR WERE DISCARDED AFTER THE INCIDENT, THEREBY PREVENTING FURTHER INVESTIGATION TO DETERMINE A DEFINITIVE ROOT CAUSE. ACCORDING TO THE CUSTOMER, THE PATIENT¿S CONDITION DETERIORATED, AND TREATMENT WAS DISCONTINUED AT THE FAMILY'S REQUEST. BASED ON THE INFORMATION PROVIDED IN CUSTOMER PRODUCT COMPLAINT SINGLE REPORT # (B)(4) (MFG REPORT #8010762-2025-0000146) AND THE COMPLETED QUESTIONNAIRE, THERE IS NO INDICATION OF A PRODUCT PERFORMANCE ISSUE. GIVEN THE LIMITED EVIDENCE AND ABSENCE OF THE INVOLVED COMPONENTS FOR FURTHER ANALYSIS, NO DEFINITIVE ROOT CAUSE FOR THE LEAKAGE CAN BE ESTABLISHED. HOWEVER, NO PRODUCT MALFUNCTION OR DIMINUTION IN PERFORMANCE IS SUSPECTED. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED BE-PAL 1723 WITH LOT# 3000356409 WAS REVIEWED ON 2025-03-28. ACCORDING TO THE DHR RESULTS, THE PRODUCT BE-PAL 1723 PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION ON MANUFACTURING ISSUES. THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. FURTHER, THE INCOMING INSPECTION REPORT REVIEW HAS BEEN PERFORMED FOR AFFECTED COMPONENT ¿700000285, 00285#KONNEKTOR 3/8 X 3/8 LL¿. THE INCOMING INSPECTION REPORT (BATCH # 3000276586) OF THE AFFECTED COMPONENT "700000285 / 00285#KONNEKTOR 3/8 X 3/8 LL" WAS REVIEWED ON 2025-03-27. THE CONNECTOR WERE CHECKED FOR DAMAGES, SCRATCHES, MARKS, RILLS, SINKS, STREAKS, AND CORDS VISUALLY. VISUAL TESTS WERE PASSED AS PER SPECIFICATIONS. DUE TO THIS, MATERIAL RELATED INFLUENCES ARE UNLIKELY. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARDS TO THE BATCH NUMBERS OF REPORTED COMPONENTS WITH RELATED TO THE REPORTED FAILURE. FURTHER, THE RELATED BASIC OPERATION PROCEDURE TRAINING RECORD HAS BEEN CONTROLLED FOR PRODUCTION EMPLOYEES AND THERE COULD NOT BE FOUND ANY NON-CONFORMITIES THAT COULD CAUSE TO REPORTED FAILURE. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND PRODUCT 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.
IT WAS REPORTED THAT THE EXTRACORPOREAL CIRCULATION CANNULA (WHERE THE FEMORAL ARTERY CATHETER IS CONNECTED) RUPTURES AND BLEEDS. IT IS UNKNOWN AT THIS MOMENT IF ANY IMMEDIATE ACTION WAS REQUIRED FOR PATIENT. SINCE THE FAILURE WAS OCCURRED DURING TREATMENT AND POTENTIAL HARM TO PATIENT WAS REPORTED, THE COMPLAINT IS REPORTABLE AS SERIOUS INJURY. COMPLAINT #(B)(4).
COMPLAINT #: (B)(4).
COMPLAINT # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2698720 | HLS CANNULAE & PIK | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | DWF | MAQUET CARDIOPULMONARY GMBH | BE-PAL 1723#BE-HLS CANNULA 17F AL | 3000356409 | 04037691589657 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male | Death| O |