BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-PLS 2050 PERMENANT LIFE SUPPORT

    MDR report key: 3804998 · Received March 6, 2014

    Report

    Report Number
    8010762-2014-00120
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    January 31, 2014
    Report Date
    February 20, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND CORRECTIVE ACTIONS FOR THE DEVICE DESCRIBED IN THIS REPORT. THE DEVICE IS NOT DISTRIBUTED IN USA BUT SIMILAR DEVICE IS DISTRIBUTED UNDER K112360. THE MFR HAS NOT RECEIVED THE DEVICE FOR INVESTIGATION. A REQUEST TO OBTAIN THE DEVICE WAS ISSUED. ONCE THE DEVICE BECAME AVAILABLE, THE INVESTIGATION WILL BEGIN TO DETERMINE THE ROOT-CAUSE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF FURTHER INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, A BLOOD LEAKAGE OCCURRED FROM THE BOTTOM OF THE PLS OXYGENATOR FROM THE GAS OUTLET PLACED ON THE BOTTOM OF THE DEVICE. REF. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136265 BE-PLS 2050 PERMENANT LIFE SUPPORT PERMENANT LIFE SUPPORT OXYGENATOR KFM MAQUET CARDIOPULMONARY AG 70105.0758 70095808

    Patients

    Seq Age Sex Outcome Treatment
    1 NI