BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3140598 · Received May 31, 2013

    Report

    Report Number
    3004209178-2013-08487
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 863740, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: PUMP. PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. PHYSICIAN PRODUCT ID: 863740, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: PUMP. PRODUCT ID: 8709, LOT# L71610, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A NORMAL PUMP REPLACEMENT. DURING THE PROCEDURE, THE NEW PUMP¿S INTERNAL TUBING HAD STARTED TO BE PRIMED. THE SURGEON WASN¿T GOING TO DRAIN THE CATHETER; THE CATHETER HAD HAD GOOD CEREBROSPINAL FLUID FLOW. IT WAS NOTED THAT ¿ONE OR TWO DROPS¿ WERE DRAINED FROM THE CATHETER. THE NEW PUMP WAS CONNECTED TO THE CATHETER BEFORE THE PRIMING BOLUS WAS COMPLETED. THE RISK OF BOLUSING THE PATIENT WAS ASSESSED, AND IT WAS DETERMINED THAT ¿IT¿LL BE FINE.¿ ONCE THE PATIENT WAS CLOSED, THE PRIMING BOLUS WAS STOPPED. THE BOLUS WAS STOPPED 14 MINUTES INTO A 19 MINUTE BOLUS. SINCE THE WATER IN THE PUMP TUBING WAS STILL IN THE SYSTEM, THERE WOULD HAVE BEEN ABOUT 12 HOURS THAT THE PATIENT WOULD HAVE BEEN WITHOUT DRUG. A 6 MINUTE PRIMING BOLUS WAS PROGRAMED IN THE PUMP. ONCE IT WAS EXPLAINED TO THE SURGEON THAT WITHDRAWAL/OVERDOSE WAS LIFE-THREATENING, THE SURGEON AGREED TO GO AHEAD AND ASPIRATE THE CATHETER. IN POST-OP, THE SURGEON WENT THROUGH THE CATHETER ACCESS PORT AND ASPIRATED FROM THE CATHETER TO ENSURE THAT THERE WAS NOTHING IN IT. WHEN THE DOCTOR ASPIRATED THAT CATHETER, IT DIDN¿T ASPIRATE EASILY, AND ONLY ABOUT 1 ML OF FLUID WAS ASPIRATED. IT WAS UNCERTAIN HOW MUCH OF THE BOLUS ACTUALLY GOT THROUGH THE CATHETER TO THE PATIENT. THE CATHETER WAS FULLY PRIMED AFTER THE ASPIRATION. THE DRUG IN THE PUMP WAS COMPOUNDED BACLOFEN AT A CONCENTRATION OF 4,000 MCG/ML. IT WAS LATER REPORTED THAT THE PATIENT HAD NO SYMPTOMS, BUT THE PATIENT¿S OUTCOME WAS UNKNOWN. TO CLARIFY, THE CATHETER ASPIRATION WAS PERFORMED POST OP FOLLOWED BY A CATHETER PRIMING BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241000 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR