BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 3930335 · Received July 11, 2014

    Report

    Report Number
    3004209178-2014-12936
    Event Type
    Death
    Date Received
    July 11, 2014
    Date of Event
    June 21, 2014
    Report Date
    May 25, 2018
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS IS NOT BEING PERFORMED AT THIS TIME DUE TO THE LEGAL STATUS OF THE EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ANALYSIS IS COMPLETED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ON 2016-06-28, ADDITIONAL INFORMATION RECEIVED FROM AN ATTORNEY REGARDING A PATIENT REPORTED THAT THE PATIENT EXPERIENCED PERSONAL INJURY AND POSSIBLY A WRONGFUL DEATH; IT WAS ALLEGED THAT THE DEVICE SYSTEM WAS DEFECTIVE AND FAILED TO DELIVER MEDICATIONS AS PRESCRIBED. THE PATIENT WAS INJURED DUE TO THE DEVICE SYSTEM'S FAILURE TO DELIVER MEDICATIONS AS PRESCRIBED, WHICH REQUIRED REMOVAL OF THE DEFECTIVE DEVICE AND SUBSEQUENT REPLACEMENT. THE INJURIES AND POSSIBLE DEATH WAS REPORTED TO HAVE OCCURRED "WITHIN THE PAST SEVERAL YEARS"; AS OF THE LETTER DATED 2016-06-21, WHICH WAS RECEIVED BY THE MANUFACTURER ON 2016-06-28. THE REPORTEDLY DEFECTIVE DEVICE SYSTEM CAUSED THE PATIENT AND THEIR FAMILY PERSONAL AND ECONOMIC INJURIES INCLUDING, BUT NOT LIMITED TO, INJURIES AND MEDICAL BILLS RELATED TO THE FAILURE OF THE DEVICE, AND INJURIES AND MEDICAL BILLS CAUSED BY THE SURGERY OR SURGERIES TO REMOVE AND REPLACE THE DEVICE. THE INJURIES THAT OCCURRED WERE NOT FURTHER SPECIFIED AND IT WAS UNCLEAR IF THE PATIENT HAD DIED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER REPORTED THE PATIENT HAD A DELIVERY FAILURE THAT RESULTED IN THE PATIENT PASSING AWAY ON AN UNKNOWN DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS A SUSPECTED OVERDOSE WHICH REQUIRED HOSPITALIZATION AND TREATMENT. THE PATIENT WAS NON-RESPONSIVE. IT WAS PLANNED TO PROGRAM THE PUMP TO MINIMUM RATE AND ASPIRATE THE CATHETER AND PUMP. A HEALTH CARE PROVIDER DID NOT PROGRAM THE PUMP TO MINIMUM RATE BECAUSE, IT WOULD NOT DO ANYTHING AND THE DRUG NEEDED TO BE REMOVED FROM THE PUMP. THE SYSTEM WAS BEING USED TO DELIVER HYDROMORPHONE AND BUPIVACAINE. IT WAS LATER REPORTED THE NEXT DAY THAT THE PATIENT WAS IN A PUMP-INDUCED OVERDOSE. THE PATIENT WAS FOUND UNRESPONSIVE IN HIS HOME BY FAMILY AND THEY CALLED AN AMBULANCE. THE PATIENT WAS TAKEN TO AN EMERGENCY ROOM AND WAS ON A NARCAN DRIP FOR 4 DAYS. THE PUMP WAS INTERROGATED AND THE PUMP DID NOT SHOW ANY INDICATION OF A FAILURE. THE PUMP HAD SALINE IN IT. THERE WAS NO REPROGRAMMING OR REFILL AROUND THE TIME OF THE OVERDOSE. THE LAST REFILL WAS AROUND (B)(6). THE PATIENT NEVER MENTIONED ANYTHING ABOUT FEELING SEDATED OR ANY ADVERSE SYMPTOMS PRIOR TO THE OVERDOSE. IT WAS THOUGHT THE EVENT WAS DUE TO OVERINFUSION. IT WAS NOTED, THE PATIENT ¿ALMOST DIED.¿ IT WAS NOTED, THE PATIENT WAS GOING TO COME TO THE CLINIC ON THE DATE OF THE REPORT WHERE THE PUMP WAS GOING TO BE SET TO MINIMUM RATE MODE, IF NOT ALREADY. IT WAS THOUGHT THERE WAS ONLY MEDICATION IN THE CATHETER AFTER REFILLING WITH SALINE FOR 15 HOURS. THE PATIENT HAD BEEN STABLE SINCE EARLIER THAT DAY AND WAS BEING TAKEN OFF NARCAN. THE DAY BEFORE, THEY TRIED TO TAKE THE PATIENT OFF NARCAN, BUT HE STARTED OVERDOSING AGAIN. THERE WERE NO ORAL MEDICATIONS FOR 3 DAYS SO THE ONLY THING THAT THE PATIENT COULD HAVE BEEN OVERDOSING ON WAS THE PUMP. THE PATIENT WAS ¿SCARED.¿ IT WAS LATER REPORTED, THE HEALTH CARE PROVIDER DID NOT HAVE PRIVILEGES AND COULD NOT PROGRAM THE PUMP TO MINIMUM RATE MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406717 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Death| H| R