BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2922739 · Received December 28, 2012

    Report

    Report Number
    1314492-2012-00555
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FLOW RATE TEST WAS PERFORMED PER THE SIGMA PREVENTIVE MAINTENANCE PROCEDURE AND THE DEVICE WAS FOUND TO DELIVER WITHIN SPECIFICATION. THE DEVICE ALSO PASSED ADD'L FLOW RATE TESTS. UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTS WERE ALSO PERFORMED PER THE SIGMA PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. THE DEVICE ALSO PASSED ADD'L UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTS. MFR REPORT # 1314492-2012-00554 AND 00556 ARE RELATED TO THIS REPORT. AT THIS TIME, THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP DID NOT PASS A FLOW RATE ACCURACY TEST (PROGRAMMED AMOUNT AND DELIVERY RATE UNK). THE CUSTOMER STATED THAT THE PUMP IS MORE THAN 10 PERCENT INACCURATE. IT WAS ALSO REPORTED THAT THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1