BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4802892 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-09859
    Event Type
    Injury
    Date Received
    May 28, 2015
    Report Date
    May 5, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8575, LOT # N132719, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY. (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

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND A MOTOR GEAR TRAIN ANOMALY DUE TO CORROSION AND/OR WEAR AND/OR LUBRICATION. THERE WAS A MOTOR STALL DUE TO SHAFT-BEARING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PUMP PROBLEM. A PATIENT REPORTED FEELING SYMPTOMS INCLUDING CRAMPING, ACHES, NAUSEA AND INCREASED PAIN STARTING THE MORNING OF THIS REPORT AT ABOUT 3:00 AM. A CRITICAL ALARM WAS HEARD AND WAS CONFIRMED BY TELEMETRY DUE TO ZERO ML RESERVOIR VOLUME REACHED AND MOTOR STALL. WHEN THE PUMP WAS READ IT WAS FOUND TO BE EMPTY AND THERE WAS ALSO A MOTOR STALL OCCURRING. THE AMOUNT DISPENSED SINCE THE LAST UPDATE WAS ABOUT 21ML. THE LOGS INDICATED THAT A LOW RESERVOIR ALARM OCCURRED (B)(6) 2015 AT 18:07, THE EMPTY RESERVOIR ALARM OCCURRED (B)(6) 2015 AT 16:59. PER THE LOGS, A MOTOR STALL OCCURRED (B)(6) 2015 AT 17:51, A RECOVERY WAS LOGGED (B)(6) 2015 AT 5:06, AND THEN THE MOTOR STALLED AGAIN (B)(6) 2015 AT 7:37. THE REPORTER STATED THAT A BOLUS WAS GIVEN AND THE HEALTHCARE PROFESSIONAL (HCP) WAS CONFUSED THAT THE PROGRAMMER ALLOWED IT EVEN THOUGH THE PUMP WAS STALLED. THE PATIENT WAS BEING ADMINISTERED ORAL BACLOFEN AND OXYCONTIN. THE PUMP WAS REPLACED AND RETURNED FOR ANALYSIS. THE PATIENT FELT BETTER PRIOR TO DISCHARGE AND WAS CURRENTLY ¿BACK TO HIS USUAL RELIEF.¿ THE PUMP WAS USED TO INFUSE BACLOFEN (COMPOUNDED), MORPHINE (UNKNOWN), AND SUFENTA (SUFENTANIL). FOLLOW UP WAS CONDUCTED TO OBTAIN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345228 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention