BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 9105836 · Received September 23, 2019

    Report

    Report Number
    3012307300-2019-04997
    Event Type
    Malfunction
    Date Received
    September 23, 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 CADD ADMINISTRATION SETS WAS RETURNED FOR ANALYSIS. THE SAMPLE CONSIST OF ONE (1) PRODUCT FROM P/N 21-7322-24 L/N 3834182; THE RETURNED SAMPLE WAS RECEIVED IN USED CONDITIONS INSIDE A PLASTIC BAG WITHOUT ITS ORIGINAL SEALED PACKAGING. ACCORDING TO THE INVESTIGATION, THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12" TO 16" UNDER NORMAL CONDITIONS OF ILLUMINATION AND 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 PERFORMED BY PRIMING USING A HYDROSTAT VESSEL [CAL. ID: 8.0088; DUE DATE: JANUARY 2020], SINCE THE DEFORMATION ON THE PUMP TUBE DO NOT ALLOW PRIMING THE DEVICE FOR GRAVITY. THEN THE SAMPLE WAS CONNECTED TO AN IV BAG AND CADD PUMP SOLIS IN ORDER TO LOOK FOR UNUSUAL FUNCTION AND THE SAMPLE WAS RECOGNIZED WITHOUT DIFFICULT AND THE PUMP WAS SET RUNNING AND NO ALARM ACTIVATED. THE CUSTOMER REPORTED PROBLEM COULD NOT BE DUPLICATED. THE INVESTIGATION REPORTED THAT ROOT CAUSE CANNOT BE DETERMINED SINCE THE COMPLAINT WAS NOT CONFIRMED DUE TO THE SAMPLE TESTING SUCCESSFULLY. NO CORRECTIVE ACTIONS REQUIRED SINCE THE COMPLAINT WAS NOT CONFIRMED; HOWEVER, PER PREVIOUS COMPLAINT A NOTIFICATION OF A COMPLAINT REGARDING THE SAME FAILURE MODE TO THE PRODUCTION PERSONNEL WAS CONDUCTED BY QUALITY ENGINEER.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING USE, THE SMITHS MEDICAL CADD ADMINISTRATION SET COULD NOT INFUSE MEDICATION AND CAUSED THE PUMP TO ALARM AN 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
    897116 CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 3834182 10610586029646

    Patients

    Seq Age Sex Outcome Treatment
    1