BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY 1 AMB INFUSION SYSTEM MODEL 6400

    MDR report key: 15066175 · Received July 20, 2022

    Report

    Report Number
    3012307300-2022-13750
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Report Date
    March 29, 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. INITIAL REPORTER OCCUPATION IS 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 TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H4: DEVICE MANUFACTURE DATE: UPDATED. H10: 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 WITH THE TAMPER SEALS INTACT. THERE WAS EVIDENCE OF FLUID INGRESSION ON THE DEVICE. THERE WAS NO EVIDENCE OF THE ERROR RECORDED IN THE EVENT HISTORY LOG. CUSTOMER PROBLEM FAILED ACCURACY WAS NOT DUPLICATED DURING THE INVESTIGATION. THE PUMP WAS FOUND TO BE UNDER DELIVERING TO THE MANUFACTURING SPECIFICATIONS. FOUND FLUID INGRESSION ON THE BASE OF EXPULSOR, WHICH WAS THE CAUSE OF THE REPORTED ISSUE. FOR CORRECTIVE ACTION IT WAS RECOMMENDED THAT THE EXPULSOR ASSEMBLY BE REPLACED. THE ROOT CAUSE OF REPORTED PROBLEM WAS TRACED TO USER INTERFACE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). PRODUCT IS BEYOND 16 YEARS FROM MANUFACTURE DATE OF 2006-12 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 2 YEARS AND THERE WAS NO INDICATION OF A SERVICE ISSUE DURING THE INVESTIGATION., CORRECTED DATA: CORRECTION: D4: MODEL NUMBER: 6400. CORRECTION: H4: MFG. DATE. 20-DEC-2006.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE FAILED ACCURACY PLUS 6.8 PERCENT DURING TESTING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405189 CADD-LEGACY 1 AMB INFUSION SYSTEM MODEL 6400 PUMP, INFUSION FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown