BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-PLS 2050#PERMANENT LIFE SUPPORT SET

    MDR report key: 4535842 · Received February 13, 2015

    Report

    Report Number
    8010762-2015-00059
    Event Type
    Malfunction
    Date Received
    February 13, 2015
    Date of Event
    January 19, 2015
    Report Date
    January 20, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS AWARE OF SIMILAR COMPLAINTS FOR THIS DEVICE. PREVIOUS INVESTIGATIONS SHOW LEAKAGE FROM THE DE-AIRING PORT. THE PORT WAS EVALUATED UNDER AN OPTICAL MICROSCOPE AND WIDE PORES WERE OBSERVED TO BE LOCALIZED IN THE MEMBRANE BODY. AN INTERNAL PROCESS (MRB 14-01-001) TO INVESTIGATE THE ROOT-CAUSE AND IMPLEMENT THE APPROPRIATE CORRECTIVE ACTION FOR THE OBSERVED DEFICIENCY HAS BEEN INITIATED. ADDITIONAL INFORMATION: THE DEVICE MENTIONED UNDER SECTION D IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ID WHICH IS REGISTERED UNDER 510(K): K101153.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, LEAKAGE WAS NOTED AT THE DE-AIRING MEMBRANE OF THE DEVICE. THE DEVICE WAS NOT REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO REPORTED PATIENT EFFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106998 BE-PLS 2050#PERMANENT LIFE SUPPORT SET CUSTOM TUBING PACK DTZ MAQUET CARDIOPULMONARY AG 70102.7818 70079588

    Patients

    Seq Age Sex Outcome Treatment
    1