BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO MULTI PERFUSION ADAPTER

    MDR report key: 13967544 · Received March 30, 2022

    Report

    Report Number
    MW5108665
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    February 23, 2022
    Report Date
    March 29, 2022
    Manufacturer
    ALLIANT ENTERPRISE, LLC / /MEDISURGE
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CARDIOPLEGIA WOULD NOT RUN AFTER CROSS CLAMP. PERFUSION TROUBLESHOT LINES AND MACHINE. CHANGED OUT MPS LINE TO THE FIELD AND MULTIPERFUSION ADAPTOR. FLUID RAN THROUGH OLD LINE BUT NOT THE MULTIPERFUSION ADAPTOR. THERE IS AN ISSUE WITH THE MULTIPERFUSION ADAPTOR. PATIENT HEART WAS NOT PERFUSED FOR APPROXIMATELY 5 MINUTES. DR. REMOVED CROSS CLAMP AFTER 2 MINUTES. AFTER LINES AND MULTIPERFUSION ADAPTOR CHANGED AND PRIMED, THE CARDIOPLEGIA RAN FINE AFTER CROSS CLAMP WAS REAPPLIED. WILL TAKE ACTION TO SENT THE ADAPTOR BACK TO THE MANUFACTURER. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872874 TERUMO MULTI PERFUSION ADAPTER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF ALLIANT ENTERPRISE, LLC / /MEDISURGE 824367 03418-121319

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention