BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3896649 · Received January 16, 2014

    Report

    Report Number
    1314492-2014-03571
    Event Type
    Malfunction
    Date Received
    January 16, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 23, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND TO BE OUT OF SPEC IN RELATION TO THE REPORTED SYMPTOM, WHICH WAS UNABLE TO BE REPRODUCED. EVAL FOUND THE LOWER READING ON THE ULTRASONIC SENSOR TO BE BELOW SPEC, CAUSED BY A FAILED UPSTREAM SENSOR. WITH LOW ULTRASONIC READINGS IT WOULD MAKE THE PUMP MORE SENSITIVE TO AIR IN LINE ALARMS. THE FAILED ULTRASONIC SENSOR WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP FALSELY ALARMED AIR IN LINE. ANY PT INJURY, INVOLVEMENT, OR MEDICAL INTERVENTION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43607 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1