BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEQ-HLS 7050 USA HLS SET ADVANCED 7.0

    MDR report key: 3993444 · Received July 24, 2014

    Report

    Report Number
    8010762-2014-00269
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS STILL UNDER INVESTIGATION. MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS. THE 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 LEAKAGE IS PERFORMED DURING PRODUCTION. MAQUET CARDIOPULMONARY (B)(4) HAS INITIATED AS INTERNAL PROCESS (CAPA(B)(4)) TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INITIATION OF THERAPY, PINK FLUID WAS OBSERVED LEAKING FROM THE GAS EXHAUST PORT OF THE DEVICE. THE DEVICE WAS EXCHANGED FOR ANOTHER. NO REPORTED PATIENT EFFECTS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435213 BEQ-HLS 7050 USA HLS SET ADVANCED 7.0 HLS MODULE ADVANCED ADULT DTZ MAQUET CARDIOPULMONARY AG 70095614

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention