BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION¿ MEDFUSION® 4000 WIRELESS SYRINGE INFUSION PUMP

    MDR report key: 6144563 · Received December 5, 2016

    Report

    Report Number
    3012307300-2016-00487
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Report Date
    November 15, 2016
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE MEDFUSION® 4000 WIRELESS SYRINGE INFUSION PUMP WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND THE PUMP IN POOR CONDITION, WITH THE TOP CASE CHIPPED AND CRACKED. A REVIEW OF THE EVENT HISTORY LOG FOUND THAT THERE WAS A FAIL-SAFE ERROR. IT WAS NOTED THAT DURING START-UP OF THE DEVICE, A BLANK SCREEN AND CONSTANT ALARM WERE OBSERVED PRIOR TO THE ERROR MESSAGE. THE CUSTOMER REPORTED ISSUE WAS REPLICATED. THE DEVICE SOFTWARE WAS RELOADED AND SUCCESSFULLY RESOLVED THE ISSUE. THE EVIDENCE SUGGESTS THAT THE REPORTED ISSUE WAS DUE TO INTERRUPTION DURING A NETWORK SYSTEM SOFTWARE DOWNLOAD TO THE DEVICE. BASED ON THE EVIDENCE, THE ROOT CAUSE IS ATTRIBUTED TO THE USER INTERFACING WITH THE DEVICE INCONSISTENT WITH ITS INDICATION FOR USE - THE PUMP-DISPLAYED INSTRUCTION TO NOT TURN OFF THE PUMP DURING A SOFTWARE UPDATE WAS NOT FOLLOWED. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE EVENT WAS CAUSED FROM AN INTRINSIC DEFECT IN THE PRODUCT.

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. (B)(4).

    Description of Event or Problem · 1

    THERE WAS NO PATIENT INVOLVEMENT OR PATIENT INJURY ASSOCIATED WITH THE REPORTED ISSUE. THE ERROR WAS DISCOVERED DURING PRE-USAGE CHECK AND CONFIRMED IN A BIOMEDICAL SHOP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDFUSION PUMP ENCOUNTERED A "CONSTANT STEADY ALARM WITH ERROR CODE "INTERRUPT.S07(0):FAIL-SAFE"." NO ADVERSE HEALTH OUTCOMES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797175 MEDFUSION¿ MEDFUSION® 4000 WIRELESS SYRINGE INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1