BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION® 3500 SYRINGE PUMP

    MDR report key: 7064413 · Received November 28, 2017

    Report

    Report Number
    3012307300-2017-02491
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Report Date
    January 30, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE MEDFUSION® 3500 SYRINGE PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. THE TAMPER SEAL WAS BROKEN. THE TOP CASE WAS BROKEN AND BOTH PLUNGER CASES WERE CRACKED. A POWER UP PROCESS REPLICATED THE SUPER CAP ERROR. AN OCCLUSION TEST UNCOVERED A MOTOR RATE ERROR. REPAIRS WERE DONE TO CORRECT THE PROBLEMS. THE FAILURE MODE WAS NORMAL WEAR. NO ROOT CAUSE WAS FOUND. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER: (B)(4), UDI (B)(4), 510K NUMBER K040899, MANUFACTURER DATE 10/31/2011.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL MEDFUSION 3500 SYRINGE PUMP RECEIVED A "SUPER CAP" POST ERROR/MOTOR ERROR MESSAGE. THERE WERE NO REPORTED ADVERSE EFFECTS. THE PRODUCT FAMILY HAZARD ANALYSIS INDICATES THAT THE DEVICE IN THE REPORTED INCIDENT IS RELATED TO A HAZARDOUS SITUATION (RMD-10001441-INTERRUPTION OF THERAPY-HAZSIT.46) AND WOULD LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL MEDFUSION® 3500 SYRINGE PUMP RECEIVED A "SUPER CAP" POST ERROR / MOTOR ERROR MESSAGE. THERE WERE NO REPORTED ADVERSE EFFECTS. THE PRODUCT FAMILY HAZARD ANALYSIS INDICATES THAT THE DEVICE IN THE REPORTED INCIDENT IS RELATED TO A HAZARDOUS SITUATION (RMD-10001441-INTERRUPTION OF THERAPY-HAZSIT.46) AND WOULD LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844490 MEDFUSION® 3500 SYRINGE PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 3500

    Patients

    Seq Age Sex Outcome Treatment
    1