BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3211121 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-11450
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 14, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S PUMP WAS SUPPOSED TO BE FILLED ON (B)(6) 2013 HOWEVER ¿THEY¿ REPORTEDLY ¿DECIDED TO LET IT GO DRY¿. THE PUMP WAS ¿SUPPOSED¿ TO HAVE RUN DRY BY (B)(6) 2013 HOWEVER, IT WAS STATED ¿I¿M STILL NOT DRY¿ AND THE PATIENT HAD NOT HEARD ANY ALARMS. IT WAS NOTED THE PUMP HAD NOT YET BEEN ACCESSED. IT WAS CONFIRMED THE DOSE HAD NOT BEEN DECREASED AT ALL AND THAT THE PUMP WAS NOT OFF, ¿THEY SAID THAT THEY WERE JUST GOING TO LET IT RUN DRY¿. THE PATIENT HAD BEEN IN THE HOSPITAL SINCE (B)(6) 2013. THE HOSPITALIZATION WAS CONFIRMED TO BE RELATED TO THE DRUG INFUSION SYSTEM AND THE PATIENT WAS ¿WAITING FOR IT TO GO OUT SO THAT THEY CAN START REGULATING MY MEDICATION¿. IT WAS THEN STATED, ¿THAT¿S WHY THEY PUT ME IN HERE SO THAT WHEN IT WENT DRY THEY WOULD BE ABLE TO MANAGE THE WITHDRAWALS. YOU KNOW IF I WENT THROUGH WITHDRAWALS¿. IT WAS THEN CONFIRMED THE PATIENT WAS ADMITTED TO MANAGE HER WITHDRAWAL SYMPTOMS. IT WAS UNCLEAR IF THE PATIENT AS OF THE DATE OF THIS REPORT WAS EXPERIENCING WITHDRAWAL SYMPTOMS. IT WAS NOTED THE PATIENT¿S PAIN WAS ¿JUST KILLING ME¿ AND SHE DIDN¿T KNOW WHAT TO DO ANYMORE ¿SO THEY CAME UP WITH THIS LET¿S DRAIN IT AND START ALL OVER¿. IT WAS REPORTED THE PATIENT HAD BEEN PLACED ON HOSPICE THREE WEEKS TO A MONTH AGO, HAD TWO TUMORS IN THE TOP OF HER BACK, HAD A ¿HOLE RIGHT ON LIKE A PRESSURE SORE DOWN ON IN THE BOTTOM OF IT¿ AND ¿I¿VE HAD A FEW IN BETWEEN THEM¿. WHEN THE PATIENT HAD REPORTEDLY INFORMED HER MANAGING PUMP HEALTH CARE PROVIDER THAT SHE WAS GOING ON HOSPICE THEY MADE HER AN APPOINTMENT ¿FOR THE MONTH IN CASE I DIDN¿T GET IN¿. HOWEVER WHEN THE PATIENT THEN CALLED AND TOLD THEM SHE WAS IN HOSPICE AND WOULD NOT MAKE IT TO THE APPOINTMENT, SHE ASKED THEM IF THERE WAS ANYTHING ELSE SHE NEEDED TO DO AND ¿NOTHING WAS EVER SAID¿. THE PATIENT WAS ¿SO CONFUSED RIGHT NOW¿ AND ¿IN SO MUCH PAIN I JUST DON¿T KNOW WHAT TO DO¿ AS OF THE DATE OF THIS REPORT AND PLANNED TO CONTACT THE NURSE THAT HANDLED HER CASE ON HOSPICE. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL, CLONIDINE, BUPIVACAINE, BACLOFEN AND MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310952 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization