BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SETS

    MDR report key: 9119475 · Received September 25, 2019

    Report

    Report Number
    3012307300-2019-04998
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    July 1, 2019
    Report Date
    January 6, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586029646
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE OF THE CADD ADMINISTRATION SET FROM P/N 21-7336-24, L/N 3834182 WAS RECEIVED IN USED CONDITION INSIDE A PLASTIC BAG WITHOUT ITS ORIGINAL PACKAGING. THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12" TO 16" UNDER NORMAL CONDITIONS OF ILLUMINATION. NO OBSTRUCTIONS NOR OTHER WORKMANSHIP DEFECTS WERE DETECTED IN NONE OF THE JOINS OF THE PRODUCT, ONLY A KINK WAS DETECTED ON THE PUMP TUBE IN THE SAMPLE CAUSED BY THE FFP SYSTEM SINCE THAT IT WAS RETURNED WITHOUT THE BLUE CLIP. FUNCTIONAL TESTING WAS CONDUCTED ON THE SAMPLE BY PRIMING IT, CONNECTING IT TO AN IV BAG AND A CADD SOLIS PUMP IN ORDER TO LOOK FOR UNUSUAL FUNCTION. THE SAMPLE WAS RECOGNIZED WITHOUT DIFFICULTY, THE PUMP WAS SET TO RUNNING AND AN ALARM WAS NOT ACTIVATED. THE REPORTED "UPSTREAM OCCLUSION ALARM" ISSUE COULD NOT BE REPLICATED. THERE WAS NO FAULT FOUND WITH THE RETURNED SAMPLE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD ADMINISTRATION SET, MEDICATION COULD NOT BE INFUSED, AND THE PUMP EXHIBITED UPSTREAM OCCLUSION ALARM WITH CONTINUOUS BEEP. THE REPORTER ALSO NOTED THAT THE ISSUE PERSISTED EVEN AFTER SWITCHING OUT MULTIPLE PUMPS. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914457 CADD ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 3834182 10610586029646

    Patients

    Seq Age Sex Outcome Treatment
    1