BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 4619383 · Received March 18, 2015

    Report

    Report Number
    8010762-2015-00248
    Event Type
    Injury
    Date Received
    March 18, 2015
    Date of Event
    February 14, 2015
    Report Date
    February 23, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTR
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD HAS NOT BEEN REQUESTED BACK FOR INVESTIGATION IN THE LAB OF THE MFR AS THE FAILURE IS KNOWN TO US. THE MALFUNCTION HAS BEEN THOROUGHLY INVESTIGATED WITHIN A PREVIOUS COMPLAINT. THE CAUSE OF THIS FAILURE WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION. BASED ON THESE RESULTS AND THE INFORMATION AVAILABLE AT THIS TIME, THE OXYGENATOR IN QUESTION OPERATED WITHIN MAQUET CARDIOPULMONARY SPEC. THIS DATA WILL BE HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS. ADD'L INFO: THE PROD MENTIONED UNDER SECTION D IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ID.

    Description of Event or Problem · 1

    ACCORDING TO CUSTOMER: "BE-PLS 2050 SET WAS PLACED TO THE PT (V ECMO) ON (B)(6) 2015 AT 11:45. ON (B)(6) 2015 AT 22:43, PO2 WAS MEASURED AND WAS 50.3 KPA (POSTOXYGENATION SAMPLE). ON THE NEXT DAY AT 10:48 H, IN POSTOXYGENATION SAMPLE OF BLOOD, PO2 WAS 10.39 KPS. THEY THEN REPEATED THE MEASUREMENT TO CHECK AND PO2 WAS 9.69 KPA. CUSTOMER HAS KEPT OXYGENATOR WHICH HAS STOPPED TO OXYGENATION AFTER 13 DAYS. THE OXYGENATOR IS STILL IN HOSPITAL IF IT IS NEEDED FOR INVESTIGATION." THE PROD WAS CHANGED OUT. NO CONSEQUENCES FOR THE PT HAVE BEEN REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184936 HLM TUBING SET W/BIOLINE COATING DTZ, DWE DTR MAQUET CARDIOPULMONARY AG BE-PLS 2050 70100023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention