BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    TERUMO CARDIOVASCULAR

    MDR report key: 18176187 · Received November 20, 2023

    Report

    Report Number
    3017540705-2023-00005
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    November 3, 2023
    Report Date
    November 20, 2023
    Manufacturer
    MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR
    Product Code
    DWF
    UDI-DI
    00817278010750
    PMA / PMN Number
    K964200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER A POUCH WAS PARTIALLY UNSEALED AT THE BOTTOM.THIS WAS IDENTIFIED PRIOR TO USE.NO INJURY/DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796569 TERUMO CARDIOVASCULAR PERFUSION SET DWF MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR 824366 06366-011823 00817278010750

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown