BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2770878 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08848
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 12, 2012
    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

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. THE PUMP PASSED ALL INFUSION, NON-DESTRUCTIVE, AND FULL DESTRUCTIVE TESTING. DISPENSE TESTING PASSED SUGGESTING THAT PUMP WAS INFUSING AS DESIGNED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: PRODUCT TYPE CATHETER. (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.

    Description of Event or Problem · 1

    THE PATIENT WAS SEEN FOR A POCKET REVISION DUE TO THE PATIENT LOSING WEIGHT. PRIOR TO THE PROCEDURE, THE PATIENT HAD REQUESTED MORE MEDICATION. DURING THE PROCEDURE, THE HCP FOUND A VOLUME DISCREPANCY AND DECIDED TO REPLACE THE PUMP. THE ACTUAL RESIDUAL VOLUME (ARV) 7.0 ML WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (ERV) 3.1 ML. THIS WAS THE FIRST DISCREPANCY NOTED WITH THE PUMP. FLUOROSCOPY WAS NOT AVAILABLE IN THE ROOM WHERE THE PROCEDURE WAS DONE SO NO ROTOR STUDY COULD BE DONE. THE LOGS WERE NOT CHECKED TO CONFIRM IF THERE WAS A STALL. THE HCP CONNECTED THE EXISTING SC CONNECTOR AND CATHETER TO THE NEW PUMP. AFTER THE REPLACEMENT THE HCP INCREASED THE DAILY DOSE. THE PROCEDURE WAS FINE AND THERE WAS NO PATIENT INJURY. THE PUMP WAS DELIVERING DURAMORPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention