BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP

    MDR report key: 14634333 · Received June 8, 2022

    Report

    Report Number
    3012307300-2022-11166
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Report Date
    October 12, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586043567
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO SMITHS/ICU MEDICAL.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED TO MANUFACTURING FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT BOTH TAMPER SEALS WERE INTACT, THE TOP AND BOTTOM CASES WERE IN GOOD CONDITION, THE RIGHT PLUNGER CASE WAS CRACKED, BUT THERE WAS NO VISIBLE CONTAMINATION UPON RECEIPT. FUNCTIONAL EVALUATION INCLUDED A POWER UP PROCESS. ERROR CODES COULD NOT BE OBTAINED FROM THE DEVICE EVENT HISTORY LOG. RESULTS: THE REPORTED EVENT WAS DUPLICATED DURING THE INVESTIGATION IN THAT THE DEVICE POWERED UP WITH CONSTANT ALARM AND WITH NO DISPLAY. ROOT CAUSE OF THE REPORTED EVENT WOULD BE ATTRIBUTED TO USER ERROR AND FROM THE DEVICE BEING USED IMPROPERLY. THE CUSTOMER MUST HAVE DOWNLOADED A PROGRAM AND DID NOT COMPLETE THE UPLOAD PROCESS. THERE WAS NO EVIDENCE OF DAMAGE OR CONTAMINATION FOUND IN THE MAIN PRINTED CIRCUIT BOARD OR INTERCONNECT BOARD. ACTIONS INCLUDED UPLOADING SOFTWARE FROM THE BASE UNIT VIA INTERCONNECT BOARD TO THE HEAD UNIT MAIN BOARD BY PERFORMING A POWER POINT PROCESS. THE FIRMWARE WAS REPROGRAMMED TO SOFTWARE VERSION V1.6.4. 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'S 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

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ADDITIONAL INFORMATION RECEIVED UPDATED B5.

    Description of Event or Problem · 0

    ORACLE RO:1233414 IT WAS REPORTED THAT WHEN POWERING THE PUMP ON, A BLANK SCREEN AND CONSTANT ALARM OCCUR. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 01-JUN-2022. THE PUMP WAS NOT IN USE ON A PATIENT AT THE TIME OF FAILURE. THE ISSUE WAS DISCOVERED ON POWER UP AND WAS NEVER INTRODUCED INTO THE PATIENT FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217927 MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP PUMP, INFUSION FRN ST PAUL 4000 10610586043567

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown