BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3221604 · Received July 3, 2013

    Report

    Report Number
    1314492-2013-00974
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 4, 2013
    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

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. A SYSTEM ERROR 322 WAS CONFIRMED THROUGH REVIEW OF THE DEVICE'S HISTORY LOG; HOWEVER IT COULD NOT BE REPRODUCED DURING THE EVAL. WHEN MONITORING THE LATCH SWITCHES ON AN OSCILLOSCOPE, IT WAS FOUND THAT THE UPPER AUX SWITCH IS INTERMITTENTLY OUTPUTTING VOLTAGE SIGNALS SPIKES WHICH CAUSED THE PUMP TO TRIGGER A SYSTEM ERROR 322 EVENT. THE UPPER AUX ASSEMBLY WAS REPLACED. SYSTEM ERROR 322 WILL OCCUR WHEN THE PUMP TRANSITIONS FROM THE DOOR OPEN STATE TO THE DOOR CLOSED/SET-LOADED STATE AND THE LOWER SWITCH DOES NOT ACTIVATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP WAS ALARMING FOR SYSTEM ERROR 322. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303603 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1