BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY 1 PUMP

    MDR report key: 14646564 · Received June 9, 2022

    Report

    Report Number
    3012307300-2022-11349
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Report Date
    March 27, 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

    A PRODUCT SAMPLE WAS RECEIVED AND IS AWAITING EVALUATION.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

    PRODUCT IS BEYOND 21 (TWENTY-ONE) YEARS FROM MANUFACTURE DATE OF 2001-02 AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED. A SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE IN THE PREVIOUS 9 YEARS AND THERE WAS NO INDICATION OF A SERVICE ISSUE DURING THE INVESTIGATION. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED. VISUAL INSPECTION FOUND CRACKED CASE AND MISSING UPPER BACK LABEL. FUNCTIONAL TESTING FOUND THE DEVICE DISPLAYING "1261" AND GOES INTO "1260" ERROR CODE ALARM MESSAGE DURING THE INVESTIGATION. THE ISSUE WAS CAUSED BY FLUID INGRESSION ON MICROPROCESSOR UNIT BOARD. MICROPROCESSOR UNIT BOARD AND SCRATCHED LCD LENS WILL BE REPLACED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE CONTAMINATED BY FLUID INGRESSION ON MPU BOARD - USER INTERFACE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10010579, AS A RESULT OF WARNING LETTER CMS# (B)(4)., CORRECTED DATA: H4: CORRECTION: DEVICE MANUFACTURING DATE: 07-FEB-2001. D4: CORRECTION: MODEL NUMBER: 6400.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERRORS APPEARED AND ALARMING OCCURRED DURING TEST; THERE WAS ALSO LENS DAMAGE OBSERVED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725062 CADD LEGACY 1 PUMP PUMP, INFUSION FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown