BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3800150 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08726
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 17, 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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH AN EMPTY RESERVOIR. ANALYSIS OF THE PUMP, INCLUDING LOG REVIEW REVEALED A MOTOR STALL RECOVERY WHICH WAS ALSO IN THE PUMP MEMORY. THIS MEANT THAT DURING PUMP LIFE THERE WAS A MOTOR STALL AND MOTOR STALL RECOVERY THAT HAD OCCURRED. DISPENSE ACCURACY TESTING PASSED. THE PUMP INFUSION HISTORY DID INDICATE ON REFILL DATE THAT THE PUMP RATE WAS ALSO INCREASED. FURTHER, DESTRUCTIVE ANALYSIS FOUND NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS EXPLANTED ON (B)(6) 2014. IT WAS NOTED THE PATIENT HAD A REFILL ON (B)(6) 2014 WITH NO DISCREPANCY AND WENT HOME. IT WAS REPORTED THERE WERE OVERDOSE SYMPTOMS AFTER REFILL. IT WAS NOTED THAT 1 HOUR AFTER THE REFILL THE PATIENT GOT VERY SICK WITH HEAVY VOMITING. IT WAS NOTED THE PATIENT WAS HOSPITALIZED, HAD NALOXONE ADMINISTERED AND THEIR SYMPTOMS IMPROVED. IT WAS NOTED THE PUMP WAS PROGRAMMED TO MINIMUM RATED AND WAS EMPTIED. THE PATIENT STATUS WAS NOTED AS ALIVE WITH NO INJURY. THE PUMP WAS USED TO DELIVER FENTANYL. ADDITIONAL INFORMATION REPORTED THE PATIENT NOW HAD THE SAME EFFECT AS WHEN THE OLD PUMP WAS FUNCTIONING WELL. IT WAS REPORTED THAT AFTER THEY EMPTIED THE RESERVOIR THERE WAS VERY LITTLE DRUG MISSING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE FOR THE DATE OF THE REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DAILY DOSE OF FENTANYL WAS 1648.6 MCG WITH A CONCENTRATION OF FENTANYL 3000 MCG/L. THE PUMP WAS REFILLED AT 09.00 AND THE SYMPTOMS OF OVERDOSE OCCURRED AT 10.00 WHICH WAS 60-70 MINUTES AFTER THE REFILL. THE PATIENT WENT HOME AT 10 O'CLOCK AND HE STARTED TO FEEL SLEEPY, VOMITING AND WENT TO BED. HE SLEPT FOR 4 HOURS AND WOKE UP AT ABOUT 14 O'CLOCK. HE WAS STILL UNWELL WITH A LOT OF NAUSEA. THE PATIENT CALLED THE HOSPITAL AND ARRIVED AT THE 15 HOUR. ACTIONS INCLUDED THE ADMINISTRATION OF NALOXONE 2 MG, INTRAVENOUSLY. THE RESERVOIR OF THE PUMP WAS EMPTIED AND 0.2 ML WAS MISSING WHICH WAS EQUIVALENT TO 600 MCG OF FENTANYL. THE PUMP WAS LEFT EMPTY AND PROGRAMMED TO 'MINIMAL FLOW; RATE. THE INTRATHECAL PUMP WAS REMOVED ON (B)(6) 2014. THE TIME BETWEEN SYMPTOMS APPEARANCE AND LIQUOR/BLOOD SAMPLE WAS 6.5 HOURS. THE LEVEL OF THE LIQUOR PUNCTURE WAS L2-L3 WITH A FENTANYL CONCENTRATION LIQUOR OF 35.14 MCG/L AND A FENTANYL CONCENTRATION BLOOD OF 6.91 MCG/L.

    Description of Event or Problem · 1

    IT WAS FURTHER CLARIFIED THAT WHEN THE PHYSICIAN EMPTIED THE PUMP 0.2ML (600 MCG) OF DRUG WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278357 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R