BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3923032 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12735
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(6). ANALYSIS OF THE PUMP FOUND THE RESERVOIR HAD 26 ML OF FLUID IN IT; THE PUMP WAS LEFT RUNNING IN SIMPLE CONTINUOUS INFUSION MODE. PUMP LOGS GATHERED AND MULTIPLE MOTOR STALL AND RECOVERIES NOTED ALONG WITH STOPPED PUMP PERIOD MAY EXCEED TUBE SET. DISPENSE ACCURACY TESTING HAD ONE TEST SHOW AN OVER INFUSION, THE RE-TEST PASSED. DESTRUCTIVE ANALYSIS FOUND THE UPPER SHAFT OF GEAR TWO WITH SIGNIFICANT RESIDUE AND THE SHAFT WAS WORN. THE PRIMARY FINDING FOR THIS ANALYSIS WILL BE BASED ON THE SHAFT WEAR. ALSO DURING DESTRUCTIVE ANALYSIS, THE PUMP TUBE SHOWS SIGNIFICANT WEAR ALONG THE SIDE OF THE TUBE WITH SOME SLIGHT ODD WEAR MARKINGS TOWARDS THE OUTLET END. ADDITIONALLY, PUMP MOTOR GEAR TRAIN ANOMALY CORROSION, AND/OR WEAR, AND/OR LUBRICATION, PUMP MOTOR GEAR TRAIN ANOMALY STALL DUE TO SHAFT-BEARING, AND OVERINFUSION OF AN UNDETERMINED ROOT CAUSE WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOTOR STALLED FOR UNKNOWN REASONS AND IT WAS UNKNOWN IF IT RECOVERED. THE HEALTH CARE PROVIDER (HCP) DECIDED TO EXPLANT THE PUMP WITHOUT ANY TROUBLESHOOTING. IT WAS NOTED TELEMETRY WAS POSSIBLE. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE,NO INJURY. THE PUMP WAS BEING USED TO DELIVER BUPRENORPHINE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS DOING FINE AND THE THERAPY WAS WORKING. IT WAS ALSO NOTED THERE WERE NO LOGS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400506 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention