BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3240927 · Received July 17, 2013

    Report

    Report Number
    1314492-2013-01352
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVAL WAS PERFORMED. THE EVAL FOUND THE UPPER READING ON THE ULTRASONIC SENSOR TO BE BELOW SPECIFICATION. LOW ULTRASONIC READINGS CAN MAKE THE PUMP MORE SENSITIVE TO UPSTREAM OCCLUSION ALARMS CAUSING THE REPORTED SYMPTOM. THE UPSTREAM SENSOR WILL BE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP CONSTANTLY ALARMS UPSTREAM OCCLUSION, INCLUDING WHEN IT IS NOT SET UP TO INFUSE. THE CUSTOMER STATED THAT THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332393 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1