BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3192389 · Received June 18, 2013

    Report

    Report Number
    1314492-2013-00806
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 CONFIRMED OR REPRODUCED. THE DEVICE WAS WITHIN SPECIFICATION AND NO MALFUNCTION COULD BE IDENTIFIED. A DOWNSTREAM OCCLUSION TEST WAS PERFORMED PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. THE PUMP PASSED ADD'L OCCLUSION TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP FAILED THE DOWNSTREAM OCCLUSION PREVENTIVE MAINTENANCE TEST. THE CUSTOMER STATED THAT THE TEST WAS PERFORMED 5 TIMES AND EACH TIME THE PUMP DID NOT ALARM UNTIL 22 PSI (SPEC = (B)(4)). THE PUMP WAS PROGRAMMED TO DELIVER 50 ML AT A RATE OF 100 ML/HR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277101 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1