BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3040555 · Received March 11, 2013

    Report

    Report Number
    1314492-2013-00219
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 11, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE EVAL COULD NOT CONFIRM A SYSTEM ERROR 322 ALARM. THE DEVICE WAS TESTED FOR OVER 7 DAYS AND DID NOT ALARM FOR A SYSTEM ERROR. REVIEW OF THE DEVICE HISTORY LOG CONFIRMS THAT THE DEVICE ALARMED FOR SYSTEM ERROR 322 MULTIPLE TIMES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARMED FOR A SYSTEM ERROR 322 WHILE DELIVERING HEPARIN TO A PT. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102574 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1