BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3896568 · Received January 16, 2014

    Report

    Report Number
    1314492-2014-03534
    Event Type
    Malfunction
    Date Received
    January 16, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 20, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO.: (B)(4). BAXTER HAS RECEIVED AND EVALUATED THE DEVICE. THE DEVICE EVALUATION WAS UNABLE TO REPRODUCE THE SYSTEM ERROR 322 DURING TESTING. HOWEVER, REVIEW OF THE DEVICE HISTORY LOG CONFIRMED THE ERROR. THE UPPER AND LOWER AUXILLIARY WERE FOUND TO BE OUT OF SPECIFICATION. THE UPPER AND LOWER AUXILIARY WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE ALARMED FOR A SYSTEM ERROR 322. ANY PT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43601 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1