BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP

    MDR report key: 13482795 · Received February 8, 2022

    Report

    Report Number
    3012307300-2022-02918
    Event Type
    Malfunction
    Date Received
    February 8, 2022
    Report Date
    February 8, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586043567
    PMA / PMN Number
    K111386
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT THERE WAS A PRIMARY AUDIBLE ALARM ISSUE ON DEVICE. TAMPER SEAL ON PLUNGER ASSEMBLY WAS TAMPERED WITH, CHIPPED OUT ON LOWER RIGHT FRONT CORNER OF TOP CASE, ALSO CRACKED ON RIGHT PLUNGER CASE AND BOTTOM CASE. PERFORMED POWER UP PROCESS, UNABLE TO DUPLICATE THE PRIMARY AUDIBLE ALARM POST ERROR AT POWER UP,UNABLE TO DETERMINE WHO CAUSE THE PROBLEM, THE J9 CONNECTOR IS FULLY SEATED AND PROPERLY GLUED (3 SURFACES - BOTH SIDE.).REPLACED SPEAKER GLUED J9 CONNECTOR (FULLY SEATED AND PROPERLY GLUED 3 SURFACES - BOTH SIDE). PERFORMED PM MAINTENANCE AND ALL FUNCTIONAL TESTING. OF TOP CASE ALSO CRACKED ON RIGHT PLUNGER CASE AND BOTTOM CASE. RESULTS OF EVENT / ERROR HISTORY LOG REVIEW: PRIMARY AUDIBLE ALARM POST - UNABLE TO DOWN LOAD THE EHL. EVALUATION TESTS OR METHODS USED TO DUPLICATE / REPLICATE THE REPORTED PROBLEMS: POWER UP. REPORTED PROBLEM DUPLICATED / REPLICATED: UNABLE TO DUPLICATE THE PRIMARY AUDIBLE ALARM POST ERROR AT POWER UP, SPEAKER TEST AT LEVEL 1 THE VALUE IS 10-10 (THE VALID RANGE 9 TO 20), AT LEVEL 5 THE VALUE IS 145-147 (THE VALID RANGE IS 130 TO 245). SPEAKER LEVEL SET AT 3, TEST VALUE 42-42 (VALID RANGE IS 32 TO 80). WHAT CAUSED THE REPORTED (PRIMARY) PROBLEM: UNABLE TO DETERMINE THE INTERMITTENT OF THE ERROR. WHO CAUSED THE REPORTED PROBLEM: UNABLE TO DETERMINE. THE J9 CONNECTOR IS FULLY SEATED AND PROPERLY GLUED (3 SURFACES ? BOTH SIDE.). ACTIONS / REPAIRS DONE TO CORRECT THE REPORTED (PRIMARY) PROBLEM: REPLACED SPEAKER GLUED J9 CONNECTOR (FULLY SEATED AND PROPERLY GLUED 3 SURFACES - BOTH SIDE). PERFORMED PM MAINTENANCE AND ALL FUNCTIONAL TESTING. PRIMARY F-CODE: S140 C006 R006 REPAIR SUMMARY: REFER TO RO # 1163261. DEVICE PASSED FUNCTIONAL / DELIVERY TESTS: REFER TO RO # 1163261. INCOMING SOFTWARE APP: V1.6.1. OUTGOING SOFTWARE APP: REFER TO RO # 1163261.COMPLAINT INVESTIGATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD PRIMARY AUDIBLE ALARM. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550107 MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP PUMPS,INFUSION FRN ST PAUL 4000 10610586043567

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown