BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 6594042 · Received May 26, 2017

    Report

    Report Number
    3008355164-2017-00012
    Event Type
    Death
    Date Received
    May 26, 2017
    Date of Event
    September 7, 2016
    Report Date
    May 26, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURER HAS REPORTED THIS EVENT UNDER MFR REPORT # 8010762-2016-00595.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: THE CUSTOMER STATED THAT SHORTLY AFTER INITIATING SUPPORT THE DELTA PRESSURE ROSE TO +400 MMHG DURING SUPPORT. AT SET UP, THE CUSTOMER STATED THAT THE TRANSDUCERS WERE NOT ABLE TO BE ZEROED TO ATMOSPHERE AS THE UNIT WAS PREVIOUSLY PRIMED. REGARDLESS, THE CUSTOMER ATTEMPTED TO ZERO THE PRESSURES WHILE THE SET WAS FILLED WITH SOLUTION BEFORE INITIATING SUPPORT. DURING SUPPORT, THE FLOWS DROPPED FROM 4.0 TO UNDER 2.0 LPM WITH AN ACCOMPANYING DROP IN PART AND PVEN. THE PINT ROSE TO +400 MMHG. NO AFFECT TO THE PATIENT WAS REPORTED. THE CUSTOMER STATED THAT THE HLS WOULD BE SAVED FOR INSPECTION. ADDITIONAL INFORMATION RECEIVED BY THE FACTORY ON MAY 1, 2017- "THE PATIENT DID DIE AFTER TREATMENT". THE MANUFACTURER REPORTED THIS EVENT UNDER MFR REPORT # 8010762-2016-00595, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375852 HLM TUBING SET W/BIOLINE COATING TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY AG BEQ-HLS 7050 USA 70110399

    Patients

    Seq Age Sex Outcome Treatment
    1 Death