BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 13085560 · Received December 25, 2021

    Report

    Report Number
    3012307300-2021-13286
    Event Type
    Malfunction
    Date Received
    December 25, 2021
    Date of Event
    November 22, 2021
    Report Date
    May 26, 2023
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4) AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW. TWO PICTURES WERE RECEIVED FROM THE CUSTOMER. PICTURE (1) SHOWS TWO CASSETTES PRODUCTS IN USED CONDITIONS, WITH MEDICATION, SLIDE CLAMP ACTIVATED AND RED CAP ATTACHED. PICTURE TWO AND PICTURE FOUR SHOW THE FRONT VIEW OF A CASSETTE PRODUCT FROM FLOW STOP MODEL. PICTURE THREE AND PICTURE FIVE SHOW THE TOP VIEW OF A CASSETTE PRODUCT FROM FLOW STOP MODEL WITHOUT BLUE CAP. SAMPLES RECEIVED: SAMPLE RECEIVED CONSISTS OF TWO CASSETTE PRODUCTS. SAMPLES WERE RECEIVED IN USED CONDITIONS WITHOUT THEIR ORIGINAL PACKAGING, DECONTAMINATED INSIDE IN A PLASTIC BAG. VISUAL INSPECTION: THE SAMPLES WERE VISUALLY INSPECTED AT A DISTANCE OF 12 IN TO 16 IN UNDER NORMAL CONDITIONS OF ILLUMINATION TO DETECT SAMPLES CONDITIONS THAT COULD CAUSE FUNCTIONAL ISSUES. RESULTS: SAMPLES WERE RECEIVED WITHOUT DAMAGE. SAMPLES WERE RECEIVED WITH SLIDE CLAMP ACTIVATED AND WITH RED CAP ASSEMBLED. PUMP TUBE HEIGHT: THE FIRST SAMPLE PUMP TUBE HEIGHT WAS 0.1083 INCH, OUT OF SPEC. THE SECOND SAMPLE PUMP TUBE HEIGHT WAS 0.1026 INCH, OUT OF SPEC. DUE SAMPLES WERE RECEIVED IN USED CONDITIONS. IT IS POSSIBLE THAT THE PUMP TUBE HEIGHT WAS MODIFIED DURING THE USE. ACCURACY TEST: THE SAMPLES COULD BE CONNECTED WITHOUT PROBLEMS. THE FIRST SAMPLE PASSED THE TEST WITH A DELIVERY RATE OF 6.77 PERCENT. THE SECOND SAMPLE FAILED THE TEST WITH A DELIVERY RATE OF 8.77 PERCENT. IT IS POSSIBLE DUE SAMPLES WERE RECEIVED IN USED CONDITIONS THESE COULD AFFECTS THE DELIVERY RATE. FUNCTIONAL TESTING: SAMPLES WERE FULLY PRIMING AND CONNECTED WITHOUT DIFFICULTY, THE PUMP WAS SET RUNNING AND NO ALARMS WERE ACTIVATED. THE REPORTED COMPLAINT WAS NOT CONFIRMED. THEREFORE, NO ROOT CAUSE WAS DETERMINED DUE COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    WHEN THE HOSPITALIZED PATIENT WAS USING THE CASSETTE IN COMBINATION WITH A PUMP (P/N: 21-6500-09, LOT NUMBER UNKNOWN), THE PUMP ISSUED AN "NO DISPOSABLE, PUMP WON'T RUN" ALARM EVERY 15 MINUTES. THEN THE CUSTOMER CHECKED THE CASSETTE AND THE PUMP BY RUNNING THEM FOR ABOUT 2 HOURS WITH THE TUBING CONNECTED. HOWEVER, NO ALARM SOUNDED. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983672 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 7302 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown