BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY 1 PUMPS

    MDR report key: 15298888 · Received August 25, 2022

    Report

    Report Number
    3012307300-2022-16278
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Report Date
    March 28, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OPERATOR OF DEVICE IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. THE DEVICE HAS NOT BEEN RETURNED. 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.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. THE CUSTOMERS REPORTED PROBLEM WAS NOT RELATED TO ANY PREVIOUS REPAIR. VISUAL INSPECTION OF THE DEVICE FOUND THE TAMPER ALL INTACT, NO PHYSICAL DAMAGE. THERE WAS NO EVIDENCE OF THE REPORTED PROBLEM RECORDED IN THE EVENT HISTORY LOG. THE REPORTED COMPLAINT WAS NOT DUPLICATED. THE DEVICE WAS PLUGGED WITH A TEST CASSETTE AND POWERED UP FOR TEN MINUTES. THERE WAS NO DOUBLE BEEPING. THE BATTERY LOSS ALARM TEST WAS PERFORMED AND PASSED. HOWEVER, HIGH PRESSURE WAS FOUND IN THE EVENT LOG MULTIPLE TIMES, AND IT WAS THEREFORE RECOMMENDED TO HAVE THE DOWN STREAM OCCLUSION SENSOR REPLACE AS PREVENTIVE ACTION. THE REPORTED PROBLEM WAS NOT CONFIRMED, AND THE SOURCE AND ROOT CAUSE WERE UNKNOWN. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10010579, AS A RESULT OF WARNING LETTER CMS# (B)(4). PRODUCT IS BEYOND 19 YEARS FROM MANUFACTURE DATE OF 2003-08 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 IN THE PREVIOUS YEAR AND THERE WAS NO INDICATION OF A SERVICE ISSUE DURING THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD A DOUBLE BEEP NO CASSETTE ERROR DURING TESTING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439690 CADD LEGACY 1 PUMPS PUMP, INFUSION FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown