BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM 60 PUMP

    MDR report key: 6830635 · Received August 30, 2017

    Report

    Report Number
    MW5071846
    Event Type
    Malfunction
    Date Received
    August 30, 2017
    Date of Event
    August 17, 2017
    Report Date
    August 18, 2017
    Manufacturer
    CSL BEHRING LLC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT'S MOM CALLED STATING THAT PROBLEM WITH THE PUMP. SHE SAID SYRINGE KEPT POPPING OUT OF PUMP AND INFUSION WAS TOO FAST. THEY DID FINISH THE INFUSION. RPH ASKED IF FLOW RATE TUBING CONNECTED, AND MOM SAID IT WAS. RPH OK'D TO HAVE PUMP EXCHANGED, BUT REMINDED MOM TO REMEMBER TO KEEP FLOW RATE TUBING CONNECTED SECURELY BEFORE INFUSING. SERIAL NUMBER UNK. PT IS SCHEDULED FOR A PUMP EXCHANGE AND WILL BE RETURNING THAT PUMP, AND NO ISSUES EXPERIENCED BY PT DUE TO PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609978 FREEDOM 60 PUMP INTRAVASCULAR ADMINISTRATION SET FPA CSL BEHRING LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR