BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SETS

    MDR report key: 18950292 · Received March 21, 2024

    Report

    Report Number
    8010762-2024-00151
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    March 7, 2024
    Report Date
    April 30, 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 NON-COMPLIANT PACKAGING WAS DETECTED. A RECEIVED PHOTOGRAPH SHOWS THAT THE FAILURE WAS DETECTED ON TYVEK AS A PERFORATION / HOLE. PRODUCT WAS NOT USED FOR TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. FURTHER, IT WAS ALSO REPORTED THAT THE IFUS WERE PLACED ON THE TYVEK INSTEAD OF THE SIDES OF THE TRAY. THE PRODUCTION HISTORY RECORDS (DHRS) OF THE AFFECTED BE-MECC 101403 WITH LOT# 3000321352 WAS REVIEWED ON 2024-04-16. ACCORDING TO THE DHR RESULTS, THE PRODUCT BE-MECC 101403 PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. FURTHER, QH 2023.02 HAS BEEN INITIATED FOR THE PRODUCT ¿BE-MECC 101403 / 701075208, V04¿. 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 THE CAPA. BASED ON THE RESULTS, AND PROVIDED PHOTOGRAPHICAL EVIDENCE, THE REPORTED FAILURE "HOLE (PERFORATION) AT TYVEK" COULD BE CONFIRMED. ACCORDING TO THE RECEIVED INFORMATION, IT WAS ALSO REPORTED THAT IFUS WERE ON THE TYVEK. ACCORDING TO THE BOP 9201240, V05, THE IFUS MUST NOT BE PLACED ON THE TYVEK. THEREFORE, PRODUCTION EMPLOYEES WERE RE-TRAINED ON BOP 9201240, V05 ON 2024-04-18. 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 NON-COMPLIANT PACKAGING WAS DETECTED. A RECEIVED PHOTOGRAPH SHOWS THAT THE FAILURE WAS DETECTED ON TYVEK AS A PERFORATION / HOLE. THE PRODUCT WAS NOT USED ON PATIENT. NO HARM TO ANY PERSON WAS REPORTED. COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532818 TUBING SETS TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY GMBH BE-MECC 101403 3000321352

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other