BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3191161 · Received June 14, 2013

    Report

    Report Number
    1314492-2013-00784
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER REC'D AND EVALUATED THE DEVICE IN QUESTION. THE REPORTED FAILED DOWNSTREAM OCCLUSION TEST COULD NOT BE REPRODUCED. THE EVALUATION FOUND THAT THE UNIT PASSED DOWNSTREAM TESTS AND THE DEVICE WAS IN SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP FAILED A DOWNSTREAM OCCLUSION TEST DURING PREVENTATIVE MAINTENANCE TESTING. THE CUSTOMER STATED THAT THE DEVICE DID NOT ALARM FOR A DOWNSTREAM OCCLUSION UNTIL 22 PSI (SPEC = 13 +/- 6PSI). IT WAS ALSO REPORTED THAT THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272147 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1