BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3221966 · Received July 5, 2013

    Report

    Report Number
    1314492-2013-01019
    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
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE IN QUESTION. THE EVALUATION CONFIRMED THE LOWER READING ON THE ULTRASONIC SENSOR TO BE BELOW SPECIFICATION CAUSED BY A FAILED UPSTREAM SENSOR. A LOW ULTRASONIC READING WILL ALLOW THE PUMP TO BECOME MORE SENSITIVE TO AIR AND UPSTREAM OCCLUSION ALARMS. THE FAILED UPSTREAM SENSOR WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARMS CONSTANTLY FOR UPSTREAM OCCLUSIONS. THE CUSTOMER STATED THAT THIS WAS OBSERVED DURING PREVENTIVE MAINTENANCE TESTING AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307116 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1