BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3062617 · Received March 19, 2013

    Report

    Report Number
    1314492-2013-00269
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 10, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THE REPORTED SYMPTOM WAS ABLE TO BE REPRODUCED. BAXTER'S EVALUATION FOUND THE SENSOR CURRENT READING TO BE OUT OF SPECIFICATION, CREATING NUISANCE DOWNSTREAM OCCLUSION ALARMS. THE DEVICE WILL NOT AUTO RESTART IF THESE ALARMS ARE OCCURRING. FURTHER EVALUATION FOUND THE DOWNSTREAM PRESSURE PLATE GAP TO BE OUT OF THE DOWNSTREAM PRESSURE PLATE GAP TO BE OUT OF SPECIFICATION. DOWNSTREAM OCCLUSION TESTS WERE PERFORMED PER SPECTRUM SVC MANUAL WITH UNIT PASSING. THE DOWNSTREAM SENSOR ASSEMBLY WILL BE REWORKED AND THE DEVICE RECALIBRATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WILL NOT AUTO RESTART AFTER A DOWNSTREAM OCCLUSION IS CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114537 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1