BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3813607 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09052
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    May 21, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PUMP, SERIAL NUMBER (B)(4), FOUND PUMP MOTOR GEAR TRAIN ANOMALY, STALL DUE TO SHAFT-BEARING. ANALYSIS FOUND A GEAR TRAIN ANOMALY FROM CORROSION, WEAR AND/OR LUBRICATION. CORRECTION: THE ANALYSIS FINDING, ¿S1 SHAFT WEAR WITH NO LUBRICATION¿ WAS INADVERTENTLY APPLIED; THIS FINDING DOES NOT APPLY TO THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP (S/N: (B)(4)) FOUND A GEAR TRAIN ANOMALY FROM CORROSION, WEAR AND/OR LUBRICATION. THERE WAS S1 SHAFT WEAR WITH NO LUBRICATION. THERE WAS CORROSION ON THE TOP SIDE OF GEAR WHEEL THREE. THERE WAS SHAFT WEAR ON THE LOWER SHAFT OF GEAR 2.

    Description of Event or Problem · 1

    IT WAS LATER CONFIRMED THAT THERE WAS NO CATHETER ISSUE. IT WAS NOTED THAT THE EXACT UNDERDOSE SYMPTOMS WERE UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS UNDERDOSING DUE TO THE VOLUME DISCREPANCY WITH AN EXPECTED VOLUME OF 5 ML AND AN ACTUAL VOLUME OF 18 ML. THE PUMP WAS REPORTEDLY EXPLANTED. THE PATIENT WAS DESCRIBED AS ALIVE WITH NO INJURY AT THE TIME OF REPORT. THE PATIENT REPORTEDLY EXPERIENCED UNDERDOSE SYMPTOMS AT THE DEVICE POCKET. THE PUMP WAS DELIVERING MORPHINE AND BUPIVACAINE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT EXPERIENCED WITHDRAWAL. THERE WAS A HISTORY OF MAGNETIC RESONANCE IMAGING (MRI). THE CAUSE OF THE STALL WAS UNKNOWN. THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY. IT WAS REPORTED THAT THERE WAS A MOTOR STALL ON (B)(6)2014 AT 8:04 A.M. AND A MOTOR STALL RECOVERY ON THE SAME DATE AT 8:39 A.M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290284 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention