BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCU

    MDR report key: 5129717 · Received September 24, 2015

    Report

    Report Number
    MW5056820
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    August 11, 2015
    Report Date
    September 23, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IV SAFETY SLIDE CLAMP (THE ONE THAT ENGAGES AUTOMATICALLY WHEN THE TUBING IS PULLED OUT) DID NOT ENGAGE AND THE MEDICATION FLOWED INTO THE PT. THE CLAMPS AND TUBING WERE NOT SAVED IN THE FIRST INCIDENT, BUT WERE FOR THE OTHER TWO INCIDENTS. EVENT #1: 4-PORT. PER RN #1, THE SAFETY SLIDE CLAMP (THE ONE THAT AUTOMATICALLY ENGAGES WHEN THE TUBING IS PULLED OUT) DID NOT ENGAGE, THE MEDICATION FLOWED DIRECTLY INTO THE PT. SYSTOLIC BLOOD PRESSURE DRAMATICALLY INCREASED TO 290. THE TUBING WAS NOT SAVED. (B)(4). SEE ALSO MW5056821 AND 5056822.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633869 PCU PCU FRN CAREFUSION
    633870 PUMP MODULE PUMP MODULE FRN CAREFUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other