BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14239845 · Received April 28, 2022

    Report

    Report Number
    3012307300-2022-07067
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Report Date
    March 6, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS#(B)(4). NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMERS REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF THE SERVICE AND REPAIR RECORDS. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION SHOWED THE UPPER BACK LABEL WAS MISSING. DURING FUNCTIONAL CHECK, THE REPORTED PROBLEM WAS DUPLICATED. RUNNING THREE ACCURACY TESTS, THE PUMP WAS FOUND TO BE OVER DELIVERING TO THE MANUFACTURING SPECIFICATIONS AND SCRATCHED LIQUID CRYSTAL DISPLAY LENS. ROOT CAUSE WAS FOUND TO BE INACCURATE DELIVERY OF THE PRODUCT. RECOMMENDED EXPULSOR TO BE TRIMMED DOWN TO BRING THE DELIVERY ACCURACY CLOSER TO NOMINAL OF A RANGE AND REPLACE SCRATCHED LIQUID CRYSTAL DISPLAY LENS.

    Description of Event or Problem · 0

    ORACLE RO 1223235: FAILS ACCURACY (B)(4), LENS DAMAGE (DURING TESTING / NO PATIENT INJURY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118984 CADD PUMP, INFUSION FRN ST PAUL 21-6400-51 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown