BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUM

    MDR report key: 14660901 · Received June 10, 2022

    Report

    Report Number
    3012307300-2022-11641
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Report Date
    March 29, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OPERATOR OF DEVICE AND INITIAL REPORTER ALSO SENT REPORT TO FDA ARE 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.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H10: 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 SEAL INTACT. THERE WAS EVIDENCE OF THE REPORTED PROBLEM ON THE PUMP DISPLAY AS WELL AS THE EVENT HISTORY LOG. CUSTOMER PROBLEM ERROR CODE 1871 WAS DUPLICATED ON THE PUMP DISPLAY DURING THE INVESTIGATION. A FAULTY MOTOR WAS FOUND LOCKED AND CAUSING THE ERROR CODE 1871 ON THE PUMP DISPLAY. IT WAS RECOMMENDED THAT THE MOTOR TO BE REPLACED AS CORRECTIVE ACTION. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS UNKNOWN. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). PRODUCT IS BEYOND 15 YEARS FROM MANUFACTURE DATE OF 2006-12 AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DHR (DEVICE HISTORY RECORD) REVIEW WAS NOT PERFORMED. A SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE IN THE PREVIOUS 2 YEARS AND THERE WAS NO INDICATION OF A SERVICE ISSUE DURING THE INVESTIGATION., CORRECTED DATA: CORRECTION: D4: MODEL NUMBER: 6400.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP HAD AN ERROR CODE 1871 DURING TESTING. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308519 CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUM PUMP, INFUSION FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown