BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD LEGACY PUMPS 6400

    MDR report key: 15319621 · Received August 30, 2022

    Report

    Report Number
    3012307300-2022-16677
    Event Type
    Injury
    Date Received
    August 30, 2022
    Report Date
    February 14, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. DEVICES ARE UNKNOWN. NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ADDITIONAL INFORMATION IN H6 AND H10. PRODUCT IS BEYOND 21 YEARS FROM MANUFACTURE DATE OF 2001-08 AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED. A SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE PREVIOUSLY. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP TURNED OFF RANDOMLY DURING USE ON THE PATIENT FOR ABOUT 3-4 HOURS. PATIENT EXPERIENCING SOME SIDE EFFECTS OF GENERAL NOT FEELING WELL. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142977 CADD LEGACY PUMPS 6400 PUMP, INFUSION FRN ST PAUL

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization