BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SETS

    MDR report key: 18759082 · Received February 22, 2024

    Report

    Report Number
    8010762-2024-00098
    Event Type
    Malfunction
    Date Received
    February 22, 2024
    Date of Event
    February 7, 2024
    Report Date
    March 8, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT HOLE WAS FOUND ON TYVEK WHILE PREPARING THE EQUIPMENT. THEREFORE, THE PRODUCT WAS NOT USED FOR TREATMENT. THE PACK IS QUARANTINED. NO HARM TO ANY PERSON HAS BEEN REPORTED. QH 2023.02 WAS INITIATED FOR THE PRODUCT ¿BE-MECC 101403 / 701075208, V04¿. FURTHER, A CAPA HAS BEEN INITIATED FOR THE REPORTED FAILURE ¿HOLE AT TYVEK / TYVEK PERFORATED¿ AND FOR THE REPORTED PRODUCT ¿BE-MECC 101403 / 701075208¿. THE ROOT CAUSE ANALYSIS AND FURTHER ACTIONS TO DETERMINE CORRECTIVE MEASURES FOR THE FAILURE WILL BE PERFORMED WITHIN THE CAPA. ALL FURTHER STEPS WILL BE PERFORMED IN ACCORDANCE TO CAPA. THE PRODUCTION HISTORY RECORDS (DHRS) OF THE AFFECTED BE-MECC 101403 WITH LOT# 3000315701 WAS ALSO REVIEWED ON 2024-02-12. ACCORDING TO THE DHR RESULTS, THE PRODUCT BE-MECC 101403 PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. BASED ON THE RESULTS, AND PROVIDED PHOTOGRAPHICAL EVIDENCE, THE REPORTED FAILURE "HOLE (PERFORATION) AT TYVEK" COULD BE CONFIRMED. 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 HOLE WAS FOUND ON TYVEK WHILE PREPARING THE EQUIPMENT. THEREFORE, THE PRODUCT WAS NOT USED FOR TREATMENT. NO HARM TO ANY PERSON WAS REPORTED. COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1642948 TUBING SETS TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY GMBH BE-MECC 101403 3000315701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other