BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSTION SET

    MDR report key: 14227522 · Received April 27, 2022

    Report

    Report Number
    3012307300-2022-07029
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    February 26, 2022
    Report Date
    June 1, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586023279
    PMA / PMN Number
    K974013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING PATIENT DETAILS AND CORRECTION TO CUSTOMER INFO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TRYING TO PRIME TUBING [LOT NUMBER 4220038] "HIGH PRESSURE" ALARMS OCCURRED ON THE PUMP. PATIENT CHANGED EXTENSION SET AND WAS ABLE PRIME TUBING SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541111 CADD EXTENSTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7106-24 4220038 10610586023279

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female