BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY 1 AMBULATORY INFUSION PUMP

    MDR report key: 14572680 · Received June 2, 2022

    Report

    Report Number
    3012307300-2022-10423
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Report Date
    November 21, 2022
    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
    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. OPERATOR OF DEVICE IS UNKNOWN. NO INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. THE CUSTOMER REPORTED PROBLEM WAS NOT RELATED TO ANY PREVIOUS REPAIR. VISUAL INSPECTION FOUND THE DEVICE IN GOOD CONDITION, ALL WAS INTACT. THERE WAS NO EVIDENCE OF THE ERROR RECORDED IN THE EVENT HISTORY LOG. THE REPORTED PROBLEM WAS DUPLICATED. RUNNING THREE ACCURACY TESTS, THE PUMP WAS FOUND TO BE OVER DELIVERING AND NOT CONSISTENT TO THE MANUFACTURING SPECIFICATIONS. THE INVESTIGATION FOUND THAT INACCURATE DELIVERY WAS THE CAUSE OF THE REPORTED PROBLEM AS THE DEVICE WAS OUT OF SPECIFICATION. FOR CORRECTIVE ACTION THE EXPULSOR ASSEMBLY WAS REPLACED TO MEET THE MANUFACTURING SPECIFICATIONS FOR ACCURACY. THE ROOT CAUSE OF REPORTED PROBLEM WAS UNKNOWN. PRODUCT IS BEYOND 20 YEARS FROM MANUFACTURE DATE OF 2002-03 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., CORRECTED DATA: CORRECTION: D4: MODEL NUMBER: 6400. CORRECTION: H4: MFG. DATE. 11-APR-2002. DATE DEVICE RETURNED TO MANUFACTURER: UPDATED TO 05/26/2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP FAILS ACCURACY TESTING. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197642 CADD-LEGACY 1 AMBULATORY INFUSION PUMP PUMP, INFUSION FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown