BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3935546 · Received February 3, 2014

    Report

    Report Number
    1314492-2014-05893
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 6, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO.: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM WHICH WAS NOT REPRODUCED. THE DEVICE WAS TESTED FOR 24 HOURS AND NO MALFUNCTION COULD BE IDENTIFIED. SYS ERROR 322 WAS CONFIRMED THROUGH THE EVENT HISTORY LOG. THE EVALUATION WAS UNABLE TO DETERMINE THE CAUSE. THE UPPER AND LOWER AUXILIARY ARE KNOWN CONTRIBUTORS TO THIS SYMPTOM AND HAVE BEEN REPLACED. SYS 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 SPECTRUM PUMP ALARMED FOR A SYS ERROR 322. IT WAS ALSO REPORTED THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69444 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1