BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3935412 · Received February 3, 2014

    Report

    Report Number
    1314492-2014-05645
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 7, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. IT WAS FOUND OUT OF SPECIFICATION WITH RESPECT TO THE REPORTED SYMPTOM. DURING A PHYSICIAN INSPECTION OF THE DEVICE, THE EVALUATION DETERMINED THE DOOR IS HARD TO CLOSE, CAUSING THE DOOR NOT FULLY LATCHED ALARM TO DISPLAY. THE DOOR HOOKS WERE FOUND OUT OF ADJUSTMENT, WHICH CAUSED THE REPORTED SYMPTOM. THE DOOR HOOKS AND LATCH PINS WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED A SPECTRUM PUMP DOES NOT RECOGNIZE A CLOSED DOOR. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71766 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1