BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3221972 · Received July 5, 2013

    Report

    Report Number
    1314492-2013-01031
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. EVALUATION FOUND THE UPPER READING ON THE ULTRASONIC SENSOR TO BE OUT OF SPECIFICATION. THIS DEFICIENCY WAS CAUSED BY A FAILED UPSTREAM SENSOR. INACCURATE ULTRASONIC READINGS WOULD MAKE THE PUMP MORE SENSITIVE TO AIR AND UPSTREAM OCCLUSION ALARMS. THE UPSTREAM SENSOR WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP ALARMED FOR UPSTREAM OCCLUSION WHEN NO OCCLUSION WAS PRESENT. THIS ISSUE WAS DISCOVERED DURING ROUTINE TESTING. THE PUMP WAS RUN USING WATER AT A RATE OF 250 ML/HR, AND AFTER 1 HOUR THE DEVICE GAVE A FALSE ALARM FOR UPSTREAM OCCLUSION. THE PUMP WAS RESTARTED, AND AFTER 10 MINUTES, IT AGAIN GAVE A FALSE ALARM. IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307117 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1