BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS CANNULA + PIK

    MDR report key: 23433836 · Received October 31, 2025

    Report

    Report Number
    8010762-2025-0000483
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 14, 2025
    Report Date
    December 16, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    UDI-DI
    04037691559131
    PMA / PMN Number
    K102532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A LEAKAGE WAS OCCURRED AT THE 7TH DAY OF TREATMENT OF ECMO OF A MALE - 48 YEARS OLD PATIENT AT INTENSIVE CARE UNIT (ICU) . AFTER CAREFUL INSPECTION, IT WAS FOUND THAT THE SIDE HOLE OF THE ECMO PERFUSION TUBE CANNULA WAS LEAKING. AFTER THE WARD ROUND, DOCTOR CONSIDERED THAT THE PATIENT HAD REACHED THE STANDARD FOR WEANING FROM THE MACHINE. AFTER REMOVING THE CANNULA, A CRACK WAS FOUND ON THE PRODUCT. NO HARM TO ANY PERSON WAS REPORTED. MORE INFORMATION HAS BEEN RECEIVED ON 2025-12-15 AS NO CONNECTION WAS PERFORMED TO THE LUER LOCK CONNECTOR HOWEVER PATIENT POSITION CHANGE WAS PERFORMED CLINICIAN SUSPECTS THE ISSUE WAS CAUSED BY PRESSURE FROM THE PATIENT TURNING OVER. 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 HOWEVER PRODUCT & MATERIAL RELATED INFLUENCES COULD NOT BE CONFIRMED AT THIS MOMENT. BASED ON THE INVESTIGATION RESULTS, THE EXACT CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED. HOWEVER, THE REPORTED FAILURE MIGHT BE RELATED WITH THE RISK ASSESSMENT FILE OF HLS CANNULAE AND POSSIBLE CAUSES WERE IDENTIFIED AS: MANUFACTURING: - USE OF WRONG OR OUT-OF-SPEC MATERIALS - INAPPROPRIATE ASSEMBLY OF COMPONENTS USER ERROR - LACK OF ATTENTION DURING DEVICE HANDLING: - MECHANICAL DAMAGE OF CANNULA DURING FIXATION - MECHANICAL DAMAGE OF CANNULA DUE TO INAPPROPRIATE FIXATION - UNINTENDED REPOSITIONING / RETRACTION OF CANNULA DURING WOUND TREATMENT. THESE ROOT CAUSES COULD NOT BE CONFIRMED. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED BE-PAS 1715 WITH LOT# 3000453879 WAS REVIEWED ON 2025-03-28. ACCORDING TO THE DHR RESULTS, THE PRODUCT BE-PAS 1715 PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. FURTHER, THE REVIEW OF THE NON-CONFORMITIES DOES NOT SHOW ANY NON-CONFORMITY IN REGARDS TO THE REPORTED PRODUCT. A REVIEW OF THE INCOMING INSPECTION REPORT OF THE CONSUMED CONNECTOR WITHIN THE FINISHED PRODUCT DID NOT SHOW ANY NON-CONFORMITIES THAT COULD CAUSE TO REPORTED FAILURE. BASED ON THESE, MATERIAL RELATED INFLUENCES WERE FOUND AS 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 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.

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LEAKAGE HAD OCCURRED AT THE 7TH DAY OF TREATMENT OF ECMO AT INTENSIVE CARE UNIT (ICU). AFTER CAREFUL INSPECTION, IT WAS FOUND THAT THE SIDE HOLE OF THE ECMO PERFUSION TUBE CANNULA WAS LEAKING. AFTER THE WARD ROUND, DOCTOR CONSIDERED THAT THE PATIENT HAD REACHED THE STANDARD FOR WEANING FROM THE MACHINE. AFTER REMOVING THE CANNULA, A CRACK WAS FOUND ON THE PRODUCT. NO HARM TO ANY PERSON WAS REPORTED. SINCE THE EVENT HAD OCCURRED DURING TREATMENT / ON PATIENT USE AND THE HAZARDOUS SITUATION BLOOD LEAKAGE OCCURRED, THE COMPLAINT IS REPORTABLE. COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878645 HLS CANNULA + PIK CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH BE-PAS 1715 3000453879 04037691559131

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Other