BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-HLS 7050#HLS SET ADVANCED 7.0

    MDR report key: 4113698 · Received September 17, 2014

    Report

    Report Number
    8010762-2014-00343
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K102726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).. MAQUET 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 (B)(4) HAS INITIATED AN INTERNAL PROCESS (B)(4) TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HLS SET WAS CONNECTED AND PRIMED WITH RINGER, NOT HEPARIN, ON (B)(6) 2014 TO BE USED IF AN EMERGENCY SITUATION WARRANTED ITS USE. THE CUSTOMER REPORTED THEY USUALLY CHANGE OUT THE SET EVERY 30 DAYS BUT MISTAKENLY DID NOT IN THIS CASE. ON (B)(6) 2014, A LEAK WAS DISCOVERED IN THE SYSTEM AND PRIME SOLUTION WAS LEAKING OUT OF THE OXYGENATOR. THE DEVICE WAS NOT USED. REF.: #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575604 BE-HLS 7050#HLS SET ADVANCED 7.0 DIFFUSION MEMBRANE OXYGENATOR DTQ MAQUET CARDIOPULMONARY AG 70097361

    Patients

    Seq Age Sex Outcome Treatment
    1