BEUDAMED
    FDA Adverse Event Death Summary report: N

    PEMCO MEDICAL PERFUSION PUMP

    MDR report key: 589692 · Received April 7, 2005

    Report

    Report Number
    589692
    Event Type
    Death
    Date Received
    April 7, 2005
    Date of Event
    March 31, 2005
    Report Date
    April 5, 2005
    Manufacturer
    PEMCO MEDICAL, INC.
    Product Code
    KFM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING INTRA-OPERATIVE PROCEDURE THE PERFUSIONIST REPORTED THAT THE PT HAD AIR IN THE AORTIC CANNULA. (DO NOT BELIEVE THIS WAS AN EQUIPMENT MALFUNCTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEMCO MEDICAL PERFUSION PUMP PERFUSION PUMP KFM PEMCO MEDICAL, INC. 5793H *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death