BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3241113 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12101
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 27, 2013
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709, LOT# J11140R46, IMPLANTED: (B)(6) 2002, EXPLANTED:UNK; PHYSICIAN PROGRAMMER: MODEL: 8840, SERIAL# UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    A CATHETER REVISION WAS REPORTED. IT WAS STATED PATIENT WAS NOT GETTING ANY MEDICATION WHICH WAS WHY THEY REPLACED THE CATHETER. HEALTHCARE PROVIDER (HCP) TRIED TO ASPIRATE BUT NOTHING CAME OUT. IT WAS ADDED THAT PATIENT WAS ON 40 MG CONCENTRATION OF MORPHINE AND CLONIDINE AND HER DOSE PER DAY WAS 20. IT WAS STATED THAT FOLLOWING REPLACEMENT DURING PROGRAMMING, IT AUTOMATICALLY WENT TO BRIDGE BOLUS BECAUSE HCP DECREASED THE CONCENTRATION; HE DILUTED IT TO 13 MG OF MORPHINE AND WANTED TO START AT 0.75; SO IT WENT AUTOMATICALLY TO BRIDGE BOLUS HOWEVER, THERE WAS STILL MEDICATION IN THE PUMP TUBING; SO THEY SET IT AT THE LOWEST RATE AS PER REPORTER WITH 40 MG CONCENTRATION SINCE PATIENT HADN'T BEEN GETTING ANYTHING, SO REPORTER EXPECTED TOOMUCH. THE PUMP WAS PROGRAMMED AT 1.9 ON A 40 MG/ML THE LOWEST DOSE THAT WAS THE DESIRED DOSE PER DAY OVER 216 HOURS, ALMOST 11 DAYS BEFORE THE DRUG GETS THROUGH THE SYSTEM. IT WAS REVIEWED THAT CONSIDERING THAT THEY DIDN'T PRIME THE CATHETER, BECAUSE OF THAT VARIABLE INTERNAL PUMP TUBING, IT WAS APPROXIMATELY FIVE DAYS WITH NO DRUG; THEN SIX DAYS OF DELIVERING WHAT WAS IN THE PUMP TUBING AND THEN BRIDGE COMPLETES, IT'S GOING TO DROP DOWN TO, THE 30 MG/ML SOLUTION, THE 0.75 THAT THEY HAD PROGRAMMED. IT WAS ADDED THAT A PRIMING BOLUS WAS NOT DONE SINCE HCP WAS IN A HURRY AND THEY PLANNED TO REDO IT THE FOLLOWING DAY. ADDITIONAL INFORMATION RECEIVED LATER INDICATED THAT PATIENT HAD EXPERIENCED NO PAIN RELIEF AND AS REPORTED PREVIOUSLY, THEY COULDN¿T ASPIRATE, HOWEVER, THE SPECIFIC LOCATION/CAUSE WAS UNKNOWN. PATIENT OUTCOME WAS UNKNOWN AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS DUE TO THE CATHETER NOT WORKING. IT WAS NOTED THE ISSUE AND THE LOCATION OF THE ISSUE WITH THE CATHETER WERE UNKNOWN. THE PATIENT EXPERIENCED SYMPTOMS OF LACK OF THERAPY. THE PATIENT RECOVERED WITHOUT SEQUELAE FOLLOWING THE CATHETER REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340877 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention