BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11164967 · Received January 13, 2021

    Report

    Report Number
    3012307300-2021-00370
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Report Date
    March 26, 2021
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: FOUR CADD CASSETTE RESERVOIRS FROM PART NUMBER 21-7302-24, LOT NUMBER 3971709 WERE RECEIVED IN USED CONDITIONS WITHOUT THEIR ORIGINAL PACKAGING. THE SAMPLES WERE VISUALLY INSPECTED AT A DISTANCE OF 12" TO 16" UNDER NORMAL CONDITIONS OF ILLUMINATION. FOR PHYSICAL EVALUATION 2 SAMPLES HAVE THE PUMP TUBE ARCHED. THE SAMPLES WERE CONNECTED TO THE CADD LEGACY PLUS PUMP AND A BALANCE METTLER TOLEDO TO PERFORM AN ACCURACY TEST. TWO SAMPLES DID NOT PASSED THE DELIVERY ACCURACY TEST. THE ISSUE WAS CAUSED BECAUSE THE PRODUCTION PERSONNEL DID NOT DETECT THAT THE ARCH TUBE WAS OUT OF SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE EVENT DATE IS BELIEVED TO BE BETWEEN (B)(6) 2020.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE CADD CASSETTE RESERVOIRS - FLOW STOP CAUSED UNDER DELIVERY. THE CUSTOMER NOTICED THE DISCREPANCY BETWEEN THE VALUE INDICATED ON THE PUMP AND THE AMOUNT ACTUALLY REMAINING IN THE CASSETTE WAS GREATER THAN 6 PERCENT. THERE WERE NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57530 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 3971709 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1