BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3160076 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10054
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    January 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0592-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED CORROSION, WEAR, AND/OR LUBRICATION OF THE MOTOR, AS WELL AS A STALL DUE TO THE SHAFT BEARING. RESIDUE AND SHAFT WEAR WERE FOUND ON THE UPPER SHAFT OF THE ROTOR MAGNET. SOME RESIDUE AND DISCOLORATION WAS ALSO FOUND ON THE JEWEL WHERE THE UPPER SHAFT OF THE ROTOR MAGNET INSERTED INTO THE TOP BRIDGE ASSEMBLY.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A FALSE MOTOR STALL DUE TO TELEMETRY STATE WAS REPORTED. THE PATIENT¿S PUMP WAS INTERROGATED ON THE DAY OF THE REPORT ABOUT AN HOUR BEFORE THE PATIENT WENT TO THE OR TO HAVE THE PUMP REPLACED DUE TO ERI. THE IMMEDIATE STATUS OF ¿MOTOR STALL OCCURRED¿ WAS OBSERVED ON THE 8840 PROGRAMMER. THE LOGS WERE READ AND THE DATE OF THE MOTOR STALL OCCURRED ON (B)(6) 2013 AT 8:55. ON (B)(6) 2013 THE LOGS READ ¿PUMP TUBE MAY HAVE EXCEEDED TUBE SET¿. THERE WAS NO LOG OF A MOTOR RECOVERY AND NO ALARMS WERE NOTED. THE DRUG EXPECTED RESIDUAL VOLUME WAS 9.3 ML¿S. THE PATIENT COMPLAINED OF INCREASED PAIN, BUT THEY COULD NOT REMEMBER IF THEY HAD WITHDRAWAL SYMPTOMS IN (B)(6). IN THE OR, THE DRUG FROM THE PUMP WAS ASPIRATED AND THE TOTAL VOLUME WAS APPROXIMATELY 10 ML¿S. THIS WAS NOTED TO BE WITHIN SPECIFICATION. THE PATIENT¿S PUMP WAS FILLED WITH PRESERVATIVE FREE SALINE, AND IT WAS DECIDED BY THE MANAGING PHYSICIAN THAT DRUG THERAPY WOULD RESUME IN ABOUT TWO WEEKS. AT THAT TIME, THE PATIENT¿S NEW PUMP WOULD BE FILLED WITH DRUG. THE PATIENT¿S STATUS WAS ALIVE AND WITHOUT INJURY. THE MEDICATIONS USED WITHIN THE SYSTEM WERE SUFENTA AND DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259677 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Other| R