BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2901360 · Received January 8, 2013

    Report

    Report Number
    3004209178-2013-00294
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 12, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PUMP WAS LAST FILLED WITH DRUG (B)(6) 2012. HCP FILLED THE PUMP WITH 20 ML OF DRUG, AND PROGRAMMED THE RESERVOIR TO 40ML. THE LOW RESERVOIR ALARM WAS TO SOUND (B)(6) 2012. IT WAS BELIEVED, THE PATIENT WAS GETTING 332 MCG OF CLONIDINE A DAY, 13.2 OF MORPHINE. THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2012 WITH CONGESTIVE HEART FAILURE (ACUTE SYSTOLIC HEART FAILURE SECONDARY TO ISCHEMIA). THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND WAS INTUBATED. THE PATIENT WAS PUT ON AN ELVAD; A HEART ASSIST PUMP. HCP'S WERE NOT SURE IF THIS WAS RELATED TO THE PUMP. THE PUMP HAD BEEN DRY SINCE OCTOBER. THE PUMP WAS NOT INTERROGATED. THE PATIENT FOLLOWED UP WITH THEIR PHYSICIAN ON (B)(6) 2012 AND WAS FINE, BUT DID HAVE PAIN. THE PUMP WAS DELIVERING MORPHINE, CLONIDINE BUPIVACAINE AND AN UNKNOWN DRUG.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THIS PUMP WAS FILLED WITH 20 CC OF MEDICATION (ABOUT A 60 DAY SUPPLY). THE PATIENT RETURNED AS SCHEDULED FOR A REFILL IN EARLY FALL TO THE PAIN MANAGEMENT CENTER (PMC). THE PREVIOUS PRESCRIPTION OF MORPHINE/BUPIVACAINE/CLONIDINE 20CC WAS RENEWED AND INJECTED INTO THE PUMP. THE PUMP WAS INTERROGATED AND SETTINGS CHANGED TO REFLECT A 5% INFUSION RATE INCREASED WITH THE RESERVOIR VOLUME SET AT 40CC THE DEFAULT SETTING FOR THIS PUMP. THE CALCULATED REFILL DATE WAS ABOUT A 120 DAY SUPPLY. THE SETTINGS WERE VERIFIED BY A FELLOW AND A NURSE. APPROXIMATELY 60 DAYS LATER THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH COMPLAINTS OF DYSPNEA AND NAUSEA. A CARDIAC CATHETERIZATION WAS PERFORMED AND A BALLOON PUMP PLACED. CLEAN CORONARIES AND A CHANGE IN EJECTION FRACTION WHICH LATER IMPROVED WERE NOTED. THE DIAGNOSIS WAS STRESS CARDIOMYOPATHY. THE HOSPITAL HAD NOT CONTACTED THE PMC DURING ADMISSION. THE PATIENT RETURNED TO THE PMC IN DECEMBER AS SCHEDULED. THE RECENT MEDICAL HISTORY NOTED A REFILL ERROR. IT WAS REPORTED THE PUMP WAS HARD TO USE IN REGARDS TO PROGRAM SETTINGS AND STORAGE AND HOW THE PUMP ALERTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. (SEE USER FACILITY MEDWATCH).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT "NONE OF THIS" CAN BE ATTRIBUTED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9959 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| L