BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT LIFE SUPPORT SET

    MDR report key: 4223531 · Received October 29, 2014

    Report

    Report Number
    8010762-2014-01060
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 28, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K102726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET (B)(4) HAS NOT RECEIVED THE DEVICE FOR EVAL. MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS. DEVICES DISPLAYED A SIMILAR MALFUNCTION WHICH WERE TESTED AND EVALUATED UNDER AN OPTICAL MICROSCOPE. DELAMINATION OF SOME GAS FIBERS WAS OBSERVED WHICH ALLOWED FOR THE PRIMING SOLUTION OR BLOOD TO FLOW INSIDE THE GAP BETWEEN THE GAS FIBERS AND POLYURETHANE. GRAVITY THEN ALLOWED FOR PASSAGE TO THE GAS EXITING PATH ALONG THE HOUSING. THE MOST PROBABLE ROOT CAUSE IS THE DELAMINATION OF THE HOLLOW GAS FIBERS FROM THE POLYURETHANE POTTING AREA. A REVIEW OF THE QUALITY CONTROL PROCESS CONFIRMS THAT 100% FUNCTIONAL INSPECTION FOR LEAKING IS PERFORMED DURING PRODUCTION. MAQUET (B)(4) HAS INITIATED AN INTERNAL PROCESS (B)(4) TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN NEW INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A RUN PERIOD OF TEN DAYS, THE DEVICE WAS CHANGED OUT. THE NEW OXYGENATOR, LOT 70098766, WAS CHANGED OUT DUE TO BLOOD LEAKAGE AT THE GAS OUTLET. APPROX 50 - 100 ML OF BLOOD WAS LOST. NO PT EFFECT WAS REPORTED. THE SECOND OXYGENATOR, LOT # 70099259 WAS ALSO CHANGED OUT DUE TO BLOOD LEAKAGE AT THE GAS OUTLET. THIS IS DEVICE 1 OF 2. REFER TO MFG REPORT 8010762-2014-01059 FOR THE SECOND DEVICE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692241 PERMANENT LIFE SUPPORT SET TUBING SET DTQ MAQUET CARDIOPULMONARY AG BE-PLS 2050 70097664

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention