BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 4797770 · Received May 22, 2015

    Report

    Report Number
    8010762-2015-00667
    Event Type
    Injury
    Date Received
    May 22, 2015
    Report Date
    April 29, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCTS. SIMILAR PRODUCTS, SHOWING A SIMILAR MALFUNCTION, HAVE BEEN TESTED AND UNDER OPTICAL MICROSCOPE A FRACTURE OF SOME GAS FIBERS WAS OBSERVED WHICH CAUSED BLOOD LEAKING FROM THE BLOOD COMPARTMENT INTO THE GAS COMPARTMENT OF THE OXYGENATOR. THE INVESTIGATION UNDER CAPA PROCESS ((B)(4)) HAS IDENTIFIED THAT THE MOST PROBABLE ROOT CAUSE IS DUE TO THE MANUFACTURING PROCESS AND THE INHERENT CHARACTERISTICS OF THE RAW MATERIAL FIBERS USED IN THE OXYGENATOR. MAQUET CARDIOPULMONARY, IN CLOSE COOPERATION WITH THE RAW MATERIAL SUPPLIERS OF THE FIBER, HAS DEFINED AN ACTION PLAN AND WILL IMPLEMENT THE APPROPRIATE CORRECTIVE ACTIONS. A SUPPLEMENTAL REPORT WILL BE PROVIDED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION D IS NOT DISTRIBUTED TO THE US, BUT THE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QUADROX-I) IS REGISTERED UNDER 510 (K) : K082117.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OXYGENATORS ARE LEAKING AT THE TIME OF PRIMING FROM THE VENT PORT 1 OUR OXYGENATORS IS LEAKING DURING THE BYPASS FROM THE VENT OF WATER HEATER COOLER. ADDITIONAL INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THREE OXYGENATOR MEMBRANE ADULT COATED HAVE BEEN FOUND LEAKAGE, TWO LEAKAGE AT THE TIME OF PRIMING AND ONE LEAKAGE FROM THE VENT PORT DURING BYPASS LOT# 70092630, 70101917, 70096675. MANUFACTURERS INFORMATION: THREE PRODUCTS HAVE BEEN COMPLAINED TO THE MANUFACTURER IN ONE COMPLAINT REPORT. ONE OF THE EVENTS OCCURED DURING PATIENT TREATMENT AND THE PRODUCT WAS REPLACED (NO CONSEQUENCES REPORTED). SINCE IT IS NOT CLEAR AS OF TODAY, WHICH OF THE EVENTS HAPPENED DURING USE ALL 3 COMPLAINTS WILL BE TREATED AS: DURING TREATMENT/PRODUCT EXCHANGED. (703005045, 703005047, 703005048). ALL REPORTED PRODUCTS ARE COMPONENTS OF TUBING SETS. INFORMATION ON THE SET WAS NOT PROVIDED. REF. : (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337638 NONE DTZ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention