BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSYSTEM III INFUSION PUMP

    MDR report key: 10553844 · Received September 18, 2020

    Report

    Report Number
    2016493-2020-09745
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Report Date
    August 24, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403928659
    PMA / PMN Number
    K933545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. THE DEVICE WAS REPAIRED, PASSED ALL REQUIRE TESTING AND SPECIFICATIONS AND RELEASED BACK TO THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED FROM 03/25/2011 TO 9/10/2020 AND CONFIRMED THAT THIS DEVICE WAS PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE PRODUCTION FAILURES WHICH DOES NOT CORRELATE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 1

    CHANNEL A REQUIRES SERVICE. IT WAS REPORTED THERE'S NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019452 MEDSYSTEM III INFUSION PUMP PUMP, INFUSION FRN CAREFUSION SD 2865B 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1