BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLS VENOUS CANNULA

    MDR report key: 4289905 · Received November 26, 2014

    Report

    Report Number
    8010762-2014-01318
    Event Type
    Death
    Date Received
    November 26, 2014
    Date of Event
    October 29, 2014
    Report Date
    October 30, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AFTER ROUTINE SET-UP, PRIMING, CANNULATION, AND SETTING THE RPMS TO 2500, FLOW COULD NOT BE ESTABLISHED TO THE PATIENT WHEN CLAMPS WERE REMOVED FROM THE TUBING. A REVIEW OF THE CIRCUIT DID NOT REVEAL ANY OBVIOUS OCCLUSION OR OBSTRUCTION. THE PATENT WAS THEN DISCONNECTED FROM THE HLS CIRCUIT AND PLACED BACK ON CONVENTIONAL CPB. THE HLS TUBING INLET AND OUTLET WERE PLACED IN A BOWL WITH FLUID AND FLOW WAS CONFIRMED. THE FLOW PROBE WAS ZEROED FOR A SECOND TIME. THE HLS CIRCUIT WAS AGAIN CONNECTED TO THE PATIENT'S CANNULAE AND SUPPORT WAS ESTABLISHED. THE CUSTOMER LATER CONVEYED THAT THEY NOW BELIEVE THAT ANY ISSUE ASSOCIATED WITH THIS REPORT CAN BE ATTRIBUTED TO A MISPLACED VENOUS CANNULAE. ON (B)(6), IT WAS REPORTED THAT THE PATIENT HAD EXPIRED AND THE CIRCUIT HAD BEEN DISCARDED". THE PATIENT WAS NOT ON CARDIOHELP SUPPORT WHEN HE EXPIRED. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769689 HLS VENOUS CANNULA DWF MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R