BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SETS - FLOW STOP

    MDR report key: 14476230 · Received May 23, 2022

    Report

    Report Number
    3012307300-2022-09448
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    April 23, 2022
    Report Date
    April 3, 2023
    Manufacturer
    ST PAUL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). ONE PICTURE WAS ATTACHED AND REVIEWED. THE PICTURE ATTACHED SHOWS A CLOSED POUCH PACKAGE. THE REPORTED FAILURE MODE IS NOT VISIBLE FROM THE PICTURE ATTACHED. THE COMPLAINT IS NOT CONFIRMED. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. BASED ON THE PICTURES PROVIDED IT'S NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE OF THE NO DELIVERY ISSUE. NO CORRECTIVE ACTIONS WERE PERFORMED SINCE ROOT CAUSE CANNOT BE DETERMINED. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW.

    Description of Event or Problem · 0

    (1/2, REFERENCE (B)(4) FOR RELATED COMPLAINTS) (DOCUMENTING ADMINISTRATION SET) IT WAS REPORTED THAT THE PUMP DID NOT INFUSE AND THE CLINICIAN HAD TO RESET THE CASSETTE AND THEN THE INFUSION STARTED. NO ALARM SOUNDED TO STATE THAT INFUSION WAS NOT RUNNING. NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM CUSTOMER ON (B)(6) 2022 AND ATTACHED BY ICU MEDICAL IN COMPLAINT: WE EXPERIENCED A PUMP RECORDING DELIVERY OF MEDICATIONS YET NOT ACTUALLY DELIVERING THE MEDICATIONS. WHEN WE CHANGED THE SET, WORKED AGAIN. WE SUSPECT THAT THERE MAY BE AN ISSUE WITH THE SETS. THE PUMP SERIAL NUMBER IS (B)(4). THE SET LOT NUMBERS ON SITE ARE LOT 4248632 AND LOT 4232350.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677069 CADD ADMINISTRATION SETS - FLOW STOP SET,ADMINISTRATION,INTRAVASCULAR FPA ST PAUL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown