BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 13585439 · Received February 23, 2022

    Report

    Report Number
    3012307300-2022-03956
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    February 9, 2022
    Report Date
    February 23, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTOGRAPHIC EVIDENCE WERE PROVIDED TO AID IN THIS INVESTIGATION. THE COMPLAINT REPORT OFFERED INSUFFICIENT DETAILS TO DETERMINE WHETHER THIS PRODUCT FUNCTIONED AS INTENDED OR WAS USED IN A MANNER CONSISTENT WITH ITS INSTRUCTIONS FOR USE (IFU) OR FAILED TO MEET PRODUCT SPECIFICATIONS. LACKING ANY ADDITIONAL EVIDENCE, THIS COMPLAINT HAS BEEN CLOSED AS UNCONFIRMED. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTOGRAPHIC EVIDENCE WERE PROVIDED TO AID IN THIS INVESTIGATION. THE COMPLAINT REPORT OFFERED INSUFFICIENT DETAILS TO DETERMINE WHETHER THIS PRODUCT FUNCTIONED AS INTENDED OR WAS USED IN A MANNER CONSISTENT WITH ITS INSTRUCTIONS FOR USE (IFU) OR FAILED TO MEET PRODUCT SPECIFICATIONS. LACKING ANY ADDITIONAL EVIDENCE, THIS COMPLAINT HAS BEEN CLOSED AS UNCONFIRMED. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NO DISPOSABLE CLAMP TUBING ALARM WAS EXPERIENCED. RES VOL IS 57.4 ML, RATE IS 3.0 ML/HR, GIVEN IS 80.60 ML. AIR PRESENT. PATIENT NOT AFFECTED. NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NO DISPOSABLE CLAMP TUBING ALARM WAS EXPERIENCED. RES VOL IS 57.4 ML, RATE IS 3.0 ML/HR, GIVEN IS 80.60 ML. AIR PRESENT. PATIENT NOT AFFECTED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632388 CADD PUMP, INFUSION FRN ST PAUL 21-6500-51 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown