BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3221504 · Received July 3, 2013

    Report

    Report Number
    1314492-2013-00991
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. EVAL FOUND LOW ULTRASONIC READINGS ON THE UPSTREAM SENSOR. LOW ULTRASONIC READINGS WOULD MAKE THE PUMP MORE SENSITIVE TO AIR IN LINE ALARMS. THE UPSTREAM SENSOR WILL BE REPLACED. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARMED AIR IN LINE WHEN NO AIR WAS PRESENT DURING AN INFUSION ON A PT. THE DEVICE WAS STOPPED AND A NEW DEVICE WAS USED TO COMPLETE THE INFUSION. THE MEDICATION THAT WAS BEING INFUSED IS UNK. THE CUSTOMER ALSO STATED THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303442 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1