BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3792467 · Received December 31, 2013

    Report

    Report Number
    1314492-2013-23934
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    December 1, 2013
    Report Date
    December 4, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE REPORTED SYMPTOM SYSTEM ERROR 322 WAS REPRODUCED DURING TESTING. THE EVALUATION WAS UNABLE TO DETERMINE THE CAUSE. UPON EVALUATION OF KNOWN CONTRIBUTORS TO SYSTEM ERROR 322 IT WAS DETERMINED THAT THE UPPER AND LOWER AUXILIARY WERE THE FAILING COMPONENTS. AS A RESULT, THE UPPER AND LOWER AUXILIARY WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS ALARMING FOR A SYSTEM ERROR 322. ANY PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683299 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1