BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2201808 · Received August 5, 2011

    Report

    Report Number
    6000030-2011-06089
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 15, 2011
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ALARM HEARD NOT CONFIRMED BY TELEMETRY WAS INITIALLY REPORTED ON (B)(6) 2011. IT WAS STATED THAT THE PUMP HAD BEEN ALARMING FOR THE LAST 2 MONTHS BUT THERE WERE NO WITHDRAWAL SYMPTOMS. THE PATIENT HAD INTENTIONALLY MISSED A REFILL ON (B)(6) 2011 AND HAD WITHDRAWAL: "TRIED PREVIOUSLY TO GO (B)(6) FOR 6 - 8 WEEKS." ON INTERROGATION THE PUMP WAS DRY/STOPPED PUMP. THE LAST REFILL WAS ON (B)(6) 2010. LATER IT WAS STATED THAT THE INTERMITTENT BEEPING FROM THE PUMP STARTED BEFORE (B)(6). PATIENT EXPERIENCED FLU SYMPTOMS A WEEK BEFORE (B)(6) 2011 AND LATER HAD SYMPTOMS OF WITHDRAWAL: NAUSEA, VOMITING. HEADACHE, COMPLETE RETURN OF THORACIC PAIN. THE PUMP WAS IN ITS (B)(6) AND DELIVERED MORPHINE. ON (B)(6) 2011, THE HEALTH CARE PROVIDER (HCP) REPORTED HAVING DIFFICULTY ACCESSING CENTER PORT. HCP HAD ATTEMPTED TO REFILL PUMP USING "40 - 50" NEEDLE STICKS BUT WAS NOT SUCCESSFUL AND PATIENT WAS SENT HOME WITHOUT REFILL OR DIAGNOSTICS. HCP LATER INFORMED PATIENT THAT PERHAPS THE PUMP HAD FLIPPED. PATIENT HAD LOST A LOT OF WEIGHT. THE NEXT DAY EFFECTS OF TOO MUCH MEDICATION WERE REPORTED: "BURNING AT PUMP, CAN'T ACCOUNT FOR 2 HOURS POST ATTEMPTED REFILL YESTERDAY, ALMOST KILLED". IT WAS STATED THAT HCP ACCIDENTALLY PUT 0.5 CC INTO PUMP WHILE ATTEMPTING TO FIND FORT. ON (B)(6) 2011, IT WAS REPORTED THAT DURING LAST REFILL A POCKET FILL WAS DONE AND THE PUMP WAS NOT FILLED. IT WAS ALSO NOTED THAT THERE WAS AN X-RAY OF PUMP THAT CONFIRMED NO FLIP AND A PHOTO OF BRUISED SKIN OVER PUMP THAT RESULTED FROM ATTEMPT TO REFILL PUMP. ON (B)(6) 2011, IT WAS REPORTED THAT PATIENT MISSED A REFILL AND EXPERIENCED WITHDRAWAL SYMPTOMS OF NAUSEA, HEADACHE, INCREASED HEART AND BLOOD PRESSURE. A NEW PUMP IMPLANT WAS BEING CONSIDERED IN 6 MONTHS. ON THE SAME DAY THE PATIENT WAS TAKEN TO THE HOSPITAL BECAUSE HE WAS IN "BAD SHAPE" AND THERE WERE CONCERNS OF INFECTION OVER PUMP POCKET, THE WHOLE LEFT SIDE OF THE BODY WAS SWOLLEN. IT WAS ALSO NOTED THAT ANTIBIOTICS WERE PRESCRIBED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11160R45