BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HQC 16602-3#HL-SET, OFFENES SYSTEM

    MDR report key: 4360447 · Received December 19, 2014

    Report

    Report Number
    8010762-2014-01380
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 20, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. A REVIEW OF THE QUALITY CONTROL PROCESS INDICATES THAT A 100% FUNCTIONAL INSPECTION FOR LEAKAGE IS PERFORMED DURING MANUFACTURING. THIS SHOULD BE ADEQUATE TO DETECT PRODUCTS THAT DO NOT MEET THE PERFORMANCE SPECIFICATIONS PRIOR TO RELEASE FOR FINAL PACKAGING AND STERILIZATION. THE TEST IS CARRIED OUT AT 1 BAR (~14 PSI) FOR A TIME PERIOD OF 75 MINUTES AT A FLOW OF 10 1/MINUTE. DURING THIS TIME EACH OXYGENATOR IS CHECKED FOR LEAKAGE. WE HAVE INTRODUCED A CUSTOMER NOTICE CONCERNING THE PROBLEM, THE POTENTIAL RISKS AND A RECOMMENDATION FOR HANDLING IN THE EVENT THIS FAILURE OCCURS. ((B)(4)). ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS NOT DISTRIBUTED TO THE US, BUT THE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT IS REGISTERED UNDER 510(K): K082117. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS SOON IF NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKAGE AS A FEW DROPS FROM THE GAS OUTLET WAS OBSERVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837672 HQC 16602-3#HL-SET, OFFENES SYSTEM CUSTOM TUBING-SET DTZ MAQUET CARDIOPULMONARY AG 70103-2529 92138750

    Patients

    Seq Age Sex Outcome Treatment
    1