BEUDAMED
    FDA Adverse Event Death Summary report: N

    70104.8012# CARDIOHELP-I

    MDR report key: 4636083 · Received March 25, 2015

    Report

    Report Number
    3008355164-2015-00046
    Event Type
    Death
    Date Received
    March 25, 2015
    Date of Event
    February 23, 2015
    Report Date
    February 24, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIOHELP DID NOT SUPPORT THE PATIENT AS EXPECTED. ALL PRESSURES BEING DISPLAYED ON THE MACHINE (PART, PVEN AND DELTAP) DROPPED. RPMS STAYED ROUGHLY AT 4000 RPMS AND FLOW DROPPED FROM 4.5L/MIN. TO NEARLY 1 L/MIN. IN ADDITION IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO GET THE FLOW BACK UP AND THERE WAS NO SUPPORT OF THE PATIENT. THE PATIENT EXPIRED. THE PATIENT WAS SUPPORTED WITH 4.51/MIN. THEREFORE A 17FR. ARTERIAL CANNULA FROM MEDTRONIC AND A VENOUS 24FR. CANNULA FROM MAQUET WAS USED. ANTICOAGULATION WAS DONE WITH HEPARIN BEFORE THE CRASH. ONE BLOOD GAS ANALYSIS WAS PERFORMED DURING THE INCIDENT AND SHOWED LOW PH, HIGH LACTATE, HIGH POTASSIUM AND LOW HB. THE CUSTOMER REPORTED THAT THERE WERE NO ALARMS WENT OFF DURING THIS INCIDENT. (B)(4). THIS EVENT IS RELATED TO MEDWATCH REPORT # 8010762-2015-00299 AND 3008355164-2015-00052 FOR THE HLS SET THAT WAS USED. REFERENCE MFR # 8010762-2015-00290.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200346 70104.8012# CARDIOHELP-I CARDIOHELLP-I DTQ MAQUET CARDIOPULMONARY AG 70104.8012

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death