BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4022796 · Received March 13, 2014

    Report

    Report Number
    1314492-2014-14459
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 17, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. EVALUATION CONFIRMED THE REPORTED SYMPTOM OF SYSTEM ERROR 322 THROUGH THE HISTORY LOG, BUT COULD NOT REPRODUCE IT. SYSTEM ERROR 322 WILL OCCUR WHEN THE PUMP TRANSITIONS FROM THE DOOR OPEN STATE TO THE DOOR CLOSED/SET-LOADED STATE AND THE LOWER LINK SWITCH DOES NOT ACTIVATE. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE THIS ISSUE. THE UPPER AND LOWER AUXILIARY ASSEMBLIES WERE REPLACED AS THEY ARE KNOWN CONTRIBUTORS TO THE REPORTED SYMPTOM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP ALARMED SYSTEM ERROR 322. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151727 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1