BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10200752 · Received June 26, 2020

    Report

    Report Number
    3012307300-2020-06271
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    May 6, 2020
    Report Date
    August 24, 2020
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027215
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H3: ONE PICTURE OF A CADD CASSETTE RESERVOIR WAS RECEIVED AND REVIEWED. THE PICTURE SHOWED A CUT IN THE PERIMETRAL SEAL OF THE ASSEMBLY (AY) BAG. TWO CADD CASSETTE RESERVOIR FROM P/N 21-7301-24 L/N 3894452 WERE RECEIVED IN USED CONDITIONS WITH THEIR ORIGINAL PACKAGING OPEN INSIDE IN A PLASTIC BAG. THE SAMPLES WERE VISUALLY INSPECTED, AT A DISTANCE OF 12 TO 24 AND NORMAL CONDITIONS OF ILLUMINATION. A CUT WAS DETECTED IN THE PERIMETRAL SEAL OF THE AY BAG. THE SAMPLE WAS VISUALLY INSPECTED, AT A DISTANCE OF 12 TO 24 AND NORMAL CONDITIONS OF ILLUMINATION. A CUT WAS DETECTED IN THE PERIMETRAL SEAL OF THE AY BAG. RELEVANT DOCUMENTS WHICH REVIEWED AND DEEMED ADEQUATE AND CORRECT WITH RESPECT TO TESTING AND INSPECTION ACTIVITIES. THE REPORTED LEAKING ISSUE WAS ABLE TO BE CONFIRMED. THE MOST PROBABLE CAUSE IS, THAT DURING LEAK TEST OPERATION CASSETTES THAT FAILED (LEAK TEST), WERE NOT PROPERLY SEGREGATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT WHEN FILLING UP MEDICAL FLUID INTO THE CASSETTE DURING A PRE-USE CHECK, THE CUSTOMER NOTICED THE FLUID WAS LEAKING FROM THE MEDICATION BAG. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666652 CADD CASSETTE RESERVOIR FPA ST PAUL 21-7301-24 3894452 10610586027215

    Patients

    Seq Age Sex Outcome Treatment
    1