BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3934073 · Received February 1, 2014

    Report

    Report Number
    1314492-2014-07283
    Event Type
    Malfunction
    Date Received
    February 1, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 14, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    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

    MANUFACTURER REF NO.: (B)(4). BAXTER RECEIVED THE DEVICE. THE SYMPTOM OF "NUISANCE AIR-IN-LINE ALARMS" WAS UNABLE TO BE REPRODUCED DURING EVALUATION. THE EVENT HISTORY LOG DID CONTAIN ENTRIES OF AIR-IN-LINE ALARMS. THE LOWER SENSOR READING FROM THE UPSTREAM SENSOR WAS FOUND TO BE BELOW SPECIFICATION. ALSO, INTERNAL EVALUATION OF THE UNIT FOUND MULTIPLE CRACKS IN THE UPSTREAM ASSEMBLY. THESE CRACKS ARE KNOWN TO CAUSE NUISANCE AIR-IN-LINE ALARMS. THE UPSTREAM SENSOR ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP WAS GIVING NUISANCE AIR-IN-LINE ALARMS. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69331 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1