BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP

    MDR report key: 14306680 · Received May 6, 2022

    Report

    Report Number
    3012307300-2022-07714
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    January 10, 2020
    Report Date
    June 3, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586023279
    PMA / PMN Number
    K974013
    Removal / Correction Number
    Z-0148-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER ASSOCIATED WITH THIS EVENT WAS NOT REPORTED. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. TUBE WAS DETACHED FROM ADAPTER TUBE. A REVIEW OF THE MANUFACTURING PROCESS FOR EXT SET P/N 21-7106-24; L/N 3935904 WAS CONDUCTED BY QUALITY ENGINEER, IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE EVENT AS DESCRIBED. NO DISCREPANCIES WERE FOUND. THE MOST PROBABLE ROOT CAUSE IS:PRODUCTION PERSONNEL DIDN'T APPLY SOLVENT PROPERLY. PRODUCTION PERSONNEL WERE RETRAINED IN ORDER TO REINFORCE THE SOLVENT APPLICATION.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE IS NOT RELATED TO A RECALL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXTENSION TUBE DISCONNECTED FROM THE CASSETTE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213255 CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7106-24 UNKNOWN 10610586023279

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown