BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE

    MDR report key: 14021035 · Received April 6, 2022

    Report

    Report Number
    3012307300-2022-05880
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    February 4, 2022
    Report Date
    May 10, 2023
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT SOURCE: (B)(6). ADDITIONAL CONTACT INFORMATION: (B)(6).

    Additional Manufacturer Narrative · 0

    H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. PICTURE ATTACHED RESULTS: PICTURE ONE SHOWS A CASSETTE PRODUCT FROM PART NUMBER 21-7302-24 AND LOT NUMBER 4163622. PICTURE TWO SHOW THE FRONT VIEW OF A CASSETTE PRODUCT. PICTURES THREE AND FOUR SHOW AN AY BAG NECK OF THE CASSETTE PRODUCT. SAMPLES RECEIVED: SAMPLE RECEIVED CONSIST IN ONE (1) CASSETTE PRODUCT FROM PART NUMBER 21-7302-24. SAMPLE WAS RECEIVED BEFORE USED, DECONTAMINATED AND INSIDE IN A PLASTIC BAG. VISUAL INSPECTION RESULTS: SAMPLE RECEIVED DON?T PRESENT ANY DAMAGED, KINK, CUT. SAMPLE WAS RECEIVED WITHOUT BLUE CLIP AND WITHOUT CAP ASSEMBLED. FUNCTIONAL TESTING: SAMPLE WAS FILLED WITH 100 ML OF WATER; THE SAMPLE WAS CONNECTED TO THE CADD LEGACY PLUS TO LOOK FOR UNUSUAL FUNCTION. RESULTS: SAMPLE WAS FULLY PRIMING AND CONNECTED WITHOUT DIFFICULT, THE PUMP WAS SET RUNNING AND NO ALARMS WERE ACTIVATED. COMPLAINT IS NOT CONFIRMED. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. THERE WERE NO RELEVANT FINDINGS DETECTED IN THE DHR.

    Additional Manufacturer Narrative · 0

    OTHER TEXT: THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS#(B)(4). PLEASE DISREGARD THE INITIAL REPORT SUBMITTED WITH THE MFR NUMBER: 3012307300-2022-05880. THE REPORT WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING THAT THE TUBING ON THE PRESSURE PLATE OF THE CADD MEDICATION CASSETTE WAS EXCESSIVELY CURVED AND THE CUSTOMER WAS NOT ABLE TO ATTACH THE CASSETTE TO A PUMP. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900836 CADD MEDICATION CASSETTE SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4163622 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female