BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITHS MEDICAL

    MDR report key: 3770948 · Received April 21, 2014

    Report

    Report Number
    MW5035756
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 20, 2014
    Manufacturer
    CADD EXTENSION SET
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE WITH PULMONARY HTN MAINTAINED ON A TREPROSTINIL INFUSION OF 196 MP/KG/MIN USING A CADD INFUSION PUMP WAS IN THE PROCESS OF PERFORMING A CASSETTE CHANGE. DONE EVERY 48HRS. THE RN HELPING THE PT HAD TO REMOVE THE PUMP FROM THE PT, ATTACH THE NEW CASSETTE AND PRIME THE NEW CADD EXTENSION SET AND REHOOK THE SETUP TO THE PT. WHILE PERFORMING THE CASSETTE CHANGE - THE SET WAS PRIMED APPROPRIATELY AND ASEPTICALLY UP TO THE POINT WHERE THE 0.22 MICRON INLINE FILTER WAS LOCATED. AT THIS POINT, THE PUMP WAS UNABLE TO PUSH ANY FLUID AT ALL THROUGH THE FILTER AND THE PUMP ALARMED AS IF OCCLUDED. THE RN HAD TO LOCATE AND REATTACH A NEW STERILE CADD EXTENSION SET FROM ANOTHER AREA OF THE HOSPITAL AND REATTACH THE INFUSION TO THE PT AS SOON AS POSSIBLE. THE OCCLUDED SET RESULTED IN THE PT BEING WITHOUT TREPROSTINIL FOR APPROX 30 MINUTES, BUT FORTUNATELY DIDN'T SUFFER ANY ILL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241671 SMITHS MEDICAL SMITHS MEDICAL FPA CADD EXTENSION SET 21-7106-24 53X368

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening| O