BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2910624 · Received December 4, 2012

    Report

    Report Number
    1314492-2012-00481
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION AND FOUND THAT THE PUMP WILL TURN ON WHEN THE CASE IS PRESSED. THIS IS CAUSED BY A FAILED UPPER HOOK SWITCH. WHEN THE PUMP IS ON AND THE CASE IS PRESSED, THE PUMP WILL NOT POWER OFF. HOWEVER, WHEN THE PUMP IS DELIVERING FLUID AND THE CASE IS PRESSED, THE PUMP WILL ALARM "DOOR OPEN," FOLLOWED BY "RELOAD SET," FOLLOWED BY "SYSTEM ERROR 322." THE DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP "TURNS ON BY JUST BEING TAPPED."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1