BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MS3 AMBULATORY INFUSION PUMP

    MDR report key: 16280390 · Received February 1, 2023

    Report

    Report Number
    3012307300-2023-00796
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Report Date
    April 12, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586029554
    PMA / PMN Number
    K051568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: WHILE PERFORMING A REVIEW OF ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER, THERE WAS NO PATIENT INVOLVEMENT, THEREFORE, NO PATIENT DEATH, SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. FILE CC-0182539 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARDS ANY REPORTS ASSOCIATED WITH IT.

    Additional Manufacturer Narrative · 0

    OPERATOR OF DEVICE IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PUMP ALARMED SYSTEM FAULT. NO FURTHER INFORMATION PROVIDED. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376502 CADD MS3 AMBULATORY INFUSION PUMP PUMP, INFUSION FRN ST PAUL 21-7411-51 10610586029554

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown