BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 WIRELESS SYRINGE INFUSION PUMP

    MDR report key: 14634328 · Received June 8, 2022

    Report

    Report Number
    3012307300-2022-11173
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Report Date
    December 8, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586032318
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO SMITHS/ICU MEDICAL.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MANUFACTURER: UPDATED. EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: A SAMPLE WAS RETURNED TO MANUFACTURING FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE TAMPER SEALS WERE BROKEN OR REMOVED UPON RECEIPT, THE TOP CASE WAS CRACKED IN THE FRONT, AND THE PLUNGER HEAD HAD CONTAMINATION. ERROR CODES WERE FOUND IN THE EHL (EVENT HISTORY LOG). THE CUSTOMER REPORTED ISSUE WAS DUPLICATED DURING THE INVESTIGATION. ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO CUSTOMER INDUCED CONTAMINATION. REPLACED THE CLUTCH HALVES LEFT AND RIGHT WITH LEADSCREW AND SPRING, WORM COUPLING AND GEAR AS PREVENTIVE MEASURE. THE PARTS WERE OVER 10 YEARS OLD. REPLACED THE BATTERY AND INTERCONNECT BOARD AS IT WOULD NOT TAKE A CHARGE. UPDATED THE MOTOR MOUNT, INSTALLED A CABLE GUARD AND PERFORMED FUNCTION AND DELIVERY TESTS. A MANUFACTURING DEVICE HISTORY RECORD DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE. NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS., CORRECTED DATA: D5: CORRECTION: OPERATOR OF DEVICE: UNKNOWN, E4: CORRECTION: INITIAL REPORTER SENT TO FDA: UNKNOWN.

    Description of Event or Problem · 0

    ORACLE RO:1233395 IT WAS REPORTED THAT A SYSTEM FAILURE OCCURRED. PATIENT INVOLVEMENT IS UNKNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 31-MAY-2022. AS FAR AS THE USERS TECHNICIAN KNOWS THERE WAS NO PATIENTS INVOLVED. THEY DID NOT SEE ANY HISTORY OTHER THAN ROUTINE PM AND A FEW CORRECTIVE MAINTENANCE FOR EACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217922 MEDFUSION 3500 WIRELESS SYRINGE INFUSION PUMP PUMP, INFUSION FRN ST PAUL 3500 10610586032318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown