BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 1033037 · Received April 22, 2008

    Report

    Report Number
    6000001-2008-00264
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL ATTEMPTS HAVE BEEN MADE TO SECURE INFO REGARDING THE MALFUNCTION OF A DEVICE THAT HAS BEEN REPORTEDLY IDENTIFIED AS A BAXTER MANUFACTURED AND MARKETED SYRINGE PUMP. CORPORATE PRODUCT SURVEILLANCE CONTINUES ITS EFFORT TO OBTAIN A SERIAL NUMBER, PRODUCT CODE, AND OTHER INFO NEEDED TO SUCCESSFULLY INVESTIGATE THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS PROVIDED BY A VOLUNTARY MEDWATCH RECEIVED BY CPS 26 MAR 2008: NURSE TITRATING PHENYLEPHRINE DOWN: DEVICE BEGAN TO BEEP AND SIGNAL: CLOSE REGULATING CLAMP. PT BLOOD PRESSURE DROPPED WHILE PUMPS WERE SWITCHED AND THEN RETURNED TO PRE-EVENT LEVEL. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK FRN BAXTER HEALTHCARE CORP. NA

    Patients

    Seq Age Sex Outcome Treatment
    1