BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11944629 · Received June 6, 2021

    Report

    Report Number
    3012307300-2021-05605
    Event Type
    Malfunction
    Date Received
    June 6, 2021
    Date of Event
    April 19, 2021
    Report Date
    December 21, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FIVE CADD CASSETTE RESERVOIRS FROM PART NUMBER 21-7302-24 AND LOT NUMBERS 4103166, 4084028 WERE RECEIVED IN NEW CONDITIONS WITHOUT THEIR ORIGINAL PACKAGE. THE SAMPLES WERE VISUALLY INSPECTED AT A DISTANCE OF 12? TO 16? UNDER NORMAL CONDITIONS OF ILLUMINATION TO DETECT SAMPLES CONDITIONS THAT COULD CAUSE FUNCTIONAL ISSUES. THE SAMPLES DIDN?T PRESENT ANY DAMAGE, SCUFFS, PINCH MARKS, CRACKS, CRAZING, ETC. COULD CAUSE THE FAILURE MODE REPORTED. THE SAMPLES WERE FILLED WITH WATER AND CONNECTED TO A CADD LEGACY PLUS PUMP TO LOOK FOR UNUSUAL FUNCTION. THE SAMPLES WERE FULLY PRIMING AND CONNECTED WITHOUT DIFFICULTY, THE PUMP WAS SET RUNNING AND THE ALARM WAS NOT ACTIVATED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED AND THERE WAS NO FAULT FOUND WITH THE RETURNED SAMPLES.

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. ELEVEN SAMPLES WERE RECEIVED FOR EVALUATION. FIVE WERE RECEIVED IN NEW CONDITION WITHOUT ITS ORIGINAL PACKING AND SIX WERE RECEIVED IN USED CONDITION, WITHOUT ITS ORIGINAL PACKAGING, DECONTAMINATED AND INSIDE IN A PLASTIC BAG. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION OBSERVED THE SAMPLES DIDN'T PRESENT ANY DAMAGE, SCUFFS, PINCH MARKS, CRACKS, CRAZING, ETC. COULD CAUSE THE FAILURE MODE REPORTED. DURING FUNCTIONAL TESTING, THE SAMPLES WERE FULLY PRIMING AND CONNECTED WITHOUT DIFFICULTLY, THE PUMP WAS SET RUNNING AND THE ALARM WAS NOT ACTIVATED. THE COMPLAINT WAS NOT CONFIRMED AND NO ACTIONS WERE TAKEN. HOWEVER, THERE IS PROCESS CONTROLS IN PLACE FOR THE FAILURE MODE REPORTED. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED. HOWEVER, PER TREND REVIEW FOR NO DISPOSABLE ALARM COMPLAINT CODE AN ESCALATION TO INVESTIGATE THIS FAILURE WAS INITIATED ON APRIL 30, 2021 UNDER NON-CONFORMANCE REPORT (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS NOT ABLE TO PROVIDE THE LOT OF THE PRODUCT INVOLVED IN THIS EVENT: IT MAY BE FROM LOT 4066530 OR 408402.

    Description of Event or Problem · 1

    CADD LEGACY PCA AND PLUS PUMPS INDICATE ?NO-DISPOSABLE ATTACHED." PER THE REPORTER: THE PROBLEM LIES WITH THE TUBING BETWEEN THE EXIT OF TUBING FROM THE CASSETTE AND THE GREEN SPRING ANTISIPHON MECHANISM. IF YOU DEPRESS THE SPRING MANUALLY AND ?ROLL THE TUBING" UPWARD SLIGHTLY YOU CAN GET THE ALARM TO STOP AND THE PRESSURE SWITCH TO RECOGNIZE THE CASSETTE AS BEING ATTACHED. NEW CASSETTE COMPOUNDED: FLUOROURACIL 3515MG 100ML:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840934 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female