BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2843730 · Received October 26, 2012

    Report

    Report Number
    1314492-2012-00375
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 27, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    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. THE EVALUATION FOUND THAT WHILE THE PUMP IS IN THE OFF STATE WHILE ON BATTERY POWER, THE UNIT CAN INTERMITTENTLY POWER UP, ENTER SLEEP MODE, AND THEN SHUTDOWN WITHOUT USER INPUT. THE UNIT ALSO EXPERIENCED "CHECK BATTERY" ALERT MESSAGES DURING THE EVALUATION. IT WAS IDENTIFIED THAT THIS IS A RESULT THAT COME IN CONTACT TO THE RIGHT SCREW OF THE SCANNER BRACKET. A SHORT BETWEEN BOTH TRACES OCCURS WHEN BOTH TRACES ARE SIMULTANEOUSLY CONTACTING THE RIGHT SCREW OF THE SCANNER BRACKET. NO KEYPAD OUTPUT RESPONSE ANOMALIES WERE APPARENT DURING THE PRODUCT EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ON/OFF KEY ON A PUMP KEYPAD WAS "STUCK". IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1