BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP

    MDR report key: 14310678 · Received May 6, 2022

    Report

    Report Number
    3012307300-2022-07833
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Report Date
    May 25, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027192
    PMA / PMN Number
    K040636
    Removal / Correction Number
    Z-0148-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION FOUND SAMPLE UNIT DO NOT PRESENT ANY DAMAGE, SCUFFS, PINCH MARKS, CRACKS, CRAZING, CUTS, ETC. COULD CAUSE THE FAILURE MODE REPORTED. FUNCTIONAL TESTING FOUND CASSETTE SAMPLE UNIT WAS FILL WITH WHITE COLORED WATER USING A SYRINGE IN ORDER TO DETECT ANY LEAKAGE. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE PROCEDURE NOT FOLLOWED. THE FORM RELATED TO THE PROCEDURES, FOR TO REGISTER UNITS WITH LEAK WERE NOT FILLING UP, AS WELL THE METHOD TO TEST THE UNITS IN PROCESS WAS NOT FOLLOWED AS IS REQUIRED, FORCING THE EQUIPMENT TO RELEASE PARTS WITH POTENTIAL LEAK CONDITION.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: WHILE PERFORMING A REVIEW OF SUBMITTED MDR REPORT IT WAS DISCOVERED THAT THIS FILE WAS INADVERTENTLY ASSESSED AS REPORTABLE. NO PATIENT DEATH, SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. FILE CC-0102484 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY MDR REPORTS ASSOCIATED WITH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED A LEAKING CADD THAT HAD CONTAINED BUPIVACAINE/SUFENTANIL (HAS BEEN FLUSHED). IT DID NOT REACH THE PATIENT. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281253 CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7300-24 4048899 10610586027192

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown