BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 3140849 · Received May 24, 2013

    Report

    Report Number
    MW5030341
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    BAXTER SIGMA INFUSION PUMP "WIRELESS BATTERY MODULE" PART NUMBER (B)(4). FOR SIGMA SPECTRUM INFUSION PUMPS. BATTERY FAILURE AND WIRELESS MODULE DUE TO FLUID MIGRATION. BATTERY CASE SCREWS MOUNT ARE CRACKING ON THE INTERNAL PORTION OF THE HOUSING ALLOWING FLUID MIGRATION AND ALSO NOTED NO SEALS ON MODULE CASE. FLUID IS SHORTING OUT THE BOARDS AND BATTERIES. THE SCREW MOUNTS ARE EXTREMELY THIN AND QUITE EASILY DAMAGED. WE HAVE HAD MINIMUM 7 BATTERIES FAILED DUE TO FLUID MIGRATION. NO ADVERSE PT EVENTS REPORTED TO THE BIOMEDICAL DEPT. (B)(4). DATES OF USE: (B)(6) 2011 - (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232828 SPECTRUM INFUSION PUMP FRN SIGMA REV G
    232829 WIRELESS BATTERY MODULE BATTERY FRN BAXTER 35162

    Patients

    Seq Age Sex Outcome Treatment
    1