BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3870916 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-11528
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    April 4, 2014
    Report Date
    May 23, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARM WAS HEARD AND CONFIRMED BY TELEMETRY TO BE A CRITICAL ALARM DUE TO AN EMPTY RESERVOIR VOLUME. THE LOW RESERVOIR VOLUME ALARM HAD OCCURRED ON (B)(6) 2014 AND THE EMPTY RESERVOIR ALARM OCCURRED ON (B)(6) 2014. THE PATIENT HAD BEEN IN A REHABILITATION FACILITY AND HEALTH CARE PROVIDERS (HCPS) WERE UNAWARE THAT THE PATIENT HAD A PUMP UNTIL RECENTLY. THE PUMP WAS REFILLED ON (B)(6) 2014. THE DRUG CONCENTRATION AND DOSE WAS LOWERED BUT THE PATIENT WAS STILL GETTING "A LOT." IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN UNRESPONSIVE BUT IT WAS UNCLEAR AS TO WHEN OR HOW THIS HAPPENED. IT WAS LATER CONFIRMED THAT THE PATIENT HAD BECOME UNRESPONSIVE AFTER THE PUMP REFILL ON THURSDAY OVERNIGHT INTO FRIDAY. THE PATIENT WAS CURRENTLY UNDERGOING REHAB. ORIGINALLY THE PUMP WAS IMPLANTED FOR FAILED BACK PAIN BUT THE PATIENT LATER FELL AND NOW HAD A SPINAL CORD INJURY. THE DEVICE SYSTEM HAD DELIVERED MORPHINE, CLONIDINE, BACLOFEN, AND BUPIVACAINE. POST REFILL, THE DEVICE WAS DELIVERING MORPHINE, BACLOFEN, AND BUPIVACAINE. THERE WAS EXPRESSED CONCERN ABOUT THE LOW RESERVOIR ALARM DATE SHOWING AS (B)(6) 2014 WHEN EXAMINED ON (B)(6) 2014 AND (B)(6) 2014 WHEN EXAMINED ON (B)(6) 2014; THE ESTIMATED ERI ON THE REPORTS CHANGING FROM 73 TO 50 AFTER THE REFILL; AND THE VOLUME DISPENSED SINCE UPDATE 80.6 ML FROM THE (B)(6) 2014 REPORT AND 79.9 ML FROM THE (B)(6) 2014 REPORT. THE CHANGES MADE AT THE REFILL RESULTED IN A HIGHER PUMP FLOW RATE WHICH AFFECTED THE ESTIMATED ERI. IT WAS SHARED THAT THE LOW RESERVOIR ALARM DATE WILL SHOW AS THE DATE THE PUMP WAS EXAMINED AFTER IT REACHES AN EMPTY STATE AND THAT THE ESTIMATED ERI ON THE PUMP CAN DROP WHEN THE FLOW RATE OF THE PUMP EXCEEDS ~0.9 ML PER DAY, WHICH IT DID ON THE CURRENT SETTING. HOWEVER, IN ALL CASES THE PUMP AND PROGRAMMER WERE WORKING AS DESIGNED. THE PHYSICIAN THEN EXPRESSED CONCERN ABOUT THE CONFUSION CAUSED BY THE LOW RESERVOIR ALARM DATE SHOWING AS THE DAY THE PUMP WAS INTERROGATED AS HE (AND SEVERAL OTHER DOCTORS) THOUGHT THAT MEANT THE PUMP JUST HAPPENED TO RUN EMPTY THAT DAY. THE PHYSICIAN EXPRESSED A DESIRE FOR THIS TO BE FIXED WITH FUTURE UPDATES TO THE PROGRAMMER OR SOFTWARE. IT WAS ALSO RECOMMENDED THAT THE PUMP WOULD AUTOMATICALLY READ LOGS ANY TIME THERE WAS AN ACTIVE ALARM SO THAT INFORMATION WOULD BE IMMEDIATELY AVAILABLE UPON INTERROGATION. ADDITIONAL INFORMATION WAS REQUESTED. IT WAS FURTHER REPORTED THAT THE PUMP WAS EMPTY FOR OVER A MONTH. REPORTEDLY, THE PATIENT WAS MOST LIKELY UNRESPONSIVE DUE TO TOO MUCH DRUG DELIVERED AFTER NOT REALIZING THE PUMP WAS EMPTY. FURTHER, THE PATIENT WAS NOW "BACK TO BASELINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347027 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Other