BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM

    MDR report key: 15184456 · Received August 8, 2022

    Report

    Report Number
    3012307300-2022-14943
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Report Date
    December 2, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 0

    H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. THE CUSTOMER REPORTED PROBLEM WAS NOT RELATED TO ANY PREVIOUS REPAIR. VISUAL INSPECTION OF THE DEVICE FOUND IT MISSING A STICKER SEAL. THERE WAS EVIDENCE OF THE ERROR FOUND IN THE EVENT HISTORY LOG. THE CUSTOMER REPORTED PROBLEM WAS VERIFIED AS THE PUMP DISPLAYED AN ERROR CODE AT START UP. THE INVESTIGATION FOUND THAT A DEFECTIVE BACK-UP-CAPACITOR WAS THE CAUSE OF THE REPORTED PROBLEM AND FOR CORRECTIVE ACTION THE BACK-UP-CAPACITOR WAS REPLACED. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS UNKNOWN. PRODUCT IS BEYOND 18 YEARS FROM MANUFACTURE DATE OF 2004-04 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., CORRECTED DATA: CORRECTION: D4: MODEL NUMBER: 6500.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ERROR CODE. THERE WAS NO REPORT OF A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026933 CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM PUMP, INFUSION FRN ST PAUL 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown