BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET WITH MALE/MALE LUER

    MDR report key: 21085978 · Received January 6, 2025

    Report

    Report Number
    3012307300-2025-00317
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    December 9, 2024
    Report Date
    January 6, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FPA
    UDI-DI
    10610586023279
    PMA / PMN Number
    K974013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: NO PRODUCT WAS RETURNED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURING. WITHOUT THE RETURN OF THE SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED AN ALARM WITH DOWNSTREAM CONCLUSION MESSAGE DISPLAYED ON THE SCREEN. PER REPORTER THE PUMP WAS CONNECTED TO A PATIENT WHEN THE ERROR/EVENT OCCURRED. THE CONTINUOUS INFUSION RATE WAS 3.3 ML/HR, TOTAL RESERVOIR VOLUME 150 ML AND GIVEN 5 ML. LOCK LEVEL: LOCKED. A CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) WAS USED TO FILL THE CASSETTE. THE METHOD THAT WAS USED TO PRIME WAS CADD SOLIS PUMP. SKU NUMBER FOR ITEMS WERE USED DURING THE INFUSION (ADMIN SET, CASSETTE ETC.) WAS CADD EXTENSION SET REFERENCE 21-7106-24, CASSETTE REFERENCE NUMBER 21-7308-24. EQUAHIELD LL-2. LOT NUMBERS FOR EACH ITEM USED (ADMIN SET, CASSETTE ETC.): CASSETTE LOT 6022069 AND CADD EXTENSION LOT 6012593. THE PUMP WAS NOT USED TO PRIME THE EXTENSION TUBING. THEY CHANGED THE EQUASHIELD BOTH MALE AND FEMALE PIECE AND TESTED THE PUMP WITHOUT ANY EQUASHIELD ON THE END AND NO FLUID FLOWED THROUGH AND PUMP ALARMED AGAIN. THEY ALSO CHANGED OUT THE PUMP AND AFTER PROGRAMMING IT WORKED CORRECTLY. THE ORIGINAL CADD TUBING WAS USED FOR SETTING UP. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950197 CADD EXTENSION SET WITH MALE/MALE LUER SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC 6012593 10610586023279

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown A CLOSED SYSTEM DRUG TRANSFER DEVICE