BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3780062 · Received January 6, 2014

    Report

    Report Number
    1314492-2014-00839
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    November 7, 2013
    Report Date
    December 9, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER'S DEVICE EVALUATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP FAILED FLOW RATE ACCURACY TESTING PER THE PREVENTIVE MAINTENANCE PROCEDURE, THREE TIMES. THE CUSTOMER STATED THAT THE PROGRAMMED RATE WAS 200ML/HR, AND THE VOLUME TO BE INFUSED WAS 50ML. EACH TIME IT WAS TESTED, THE OUTPUT WAS LESS THAN 38 ML AND THIS INDICATES AN UNDER INFUSION OF <10%. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8221 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1