BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIRS - FLOW STOP

    MDR report key: 13085533 · Received December 25, 2021

    Report

    Report Number
    3012307300-2021-13285
    Event Type
    Malfunction
    Date Received
    December 25, 2021
    Date of Event
    November 22, 2021
    Report Date
    April 27, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS#(B)(4). FIVE PICTURES WERE ATTACHED AND REVIEWED. PICTURE ONE SHOWS TWO CASSETTES 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. TWO SAMPLES WERE RECEIVED. THE SAMPLES WERE RECEIVED IN USED CONDITION WITHOUT ITS ORIGINAL PACKAGING, DECONTAMINATED INSIDE IN A PLASTIC BAG. DURING VISUAL INSPECTION, THE SAMPLES WERE VISUALLY INSPECTED UNDER NORMAL CONDITIONS OF ILLUMINATION TO DETECT CONDITIONS THAT COULD CAUSE FUNCTIONAL ISSUES. SAMPLES WERE RECEIVED WITHOUT DAMAGED. SAMPLES WERE RECEIVED WITH SLIDE CLAMP ACTIVATED AND WITH RED CAP ASSEMBLED. DURING PUMP TUBE HEIGHT CHECK, THE FIRST SAMPLE PUMP TUBE HEIGHT WAS OUT OF SPECIFICATION. THE SECOND SAMPLE PUMP TUBE HEIGHT WAS OUT OF SPECIFICATION. DUE SAMPLES BEING RECEIVED IN USED CONDITION IT IS POSSIBLE THAT THE PUMP TUBE HEIGHT WAS MODIFIED DURING USE. DURING ACCURACY TESTING, THE SAMPLES COULD BE CONNECTED WITHOUT PROBLEMS. FIRST SAMPLE PASSED THE TEST AND THE SECOND SAMPLE FAILED. IT IS POSSIBLE DUE TO THE SAMPLES BEING RECEIVED IN USED CONDITION; THIS COULD AFFECT THE DELIVERY RATE. DURING FUNCTIONAL TESTING: SAMPLES WERE FULLY PRIMING AND CONNECTED WITHOUT DIFFICULTLY, THE PUMP WAS SET RUNNING AND NO ALARMS WERE ACTIVATED. COMPLAINT IS NOT CONFIRMED. ROOT CAUSE COULD NOT BE DETERMINED, NO ACTIONS TAKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 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
    1983652 CADD CASSETTE RESERVOIRS - FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 73001 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown