BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3982999 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-14001
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 14, 2014
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A PUMP PROBLEM WAS REPORTED. THE ACTUAL RESIDUAL VOLUME (ARV) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (ERV), ARV: 15 ML AND ERV: 2 ML. THE PATIENT¿S PUMP WAS REFILLED (B)(6) AND THE PATIENT WENT TO THE CLINIC THE DAY OF REPORT ((B)(4) 2014) FOR A REFILL. THE HEALTH CARE PROFESSIONAL NOTICED THE VOLUME DISCREPANCY UPON DOING THE REFILL. THE PATIENT WAS REPORTEDLY NOT SYMPTOMATIC AND WAS GETTING GOOD THERAPY. THERE IS A QUESTION ON WHETHER THE PUMP WAS ACTUALLY REFILLED ON (B)(6). BASED ON A (B)(6) REFILL, THERE WOULD BE AROUND 15 ML (ERV). THE PUMP WAS USED TO INFUSE DILAUDID. IT WAS REPORTED SEVEN DAY LATER THAT A DYE STUDY WAS RESCHEDULED TO BE PERFORMED ON (B)(6) 2014. IT WAS REPORTED THAT ON (B)(6) 2014 THE ACTUAL RESIDUAL VOLUME (ARV) WAS GREATER THAN EXPECTED RESIDUAL VOLUME, ARV: 13-14 AND ERV: 2 ML. THE PATIENT HAD A REFILL ON (B)(6) 2014 AND WAS BROUGHT BACK TO THE CLINIC THE DAY OF REPORT ((B)(4) 2014) AND ARV: 20 ML AND ERV: 15.6 ML. THE PATIENT DEVELOPED DIFFUSE SUDDEN ONSET OF BREAKTHROUGH PAIN THE BEGINNING OF (B)(6) 2014. THE PUMP LOGS WERE CHECKED AND THERE WERE NO MOTOR STALL OCCURRENCES. THE HEALTH CARE PROFESSIONAL DECIDED NOT TO DO A ROLLER STUDY SINCE THERE ARE NO ALARMS CURRENTLY OCCURRING. A DYE STUDY WAS PERFORMED AT WHICH TIME THEY COULD NOT ASPIRATE THE CATHETER AND IT WAS DETERMINED THAT THE PUMP HAD ROTATED 180 DEGREES. THEY WERE WONDERING ABOUT A POSSIBLE KINK OR OCCLUSION. THE PATIENT¿S HEALTH CARE PROFESSIONAL (HCP) FILLED THE PUMP ON (B)(6) 2014 WITH A FULL 20 ML. THE HCP ASPIRATED A FULL ML FROM THE PUMP. THE PATIENT¿S HCP WAS PLANNING A CATHETER REPLACEMENT. THE INFUSION WAS SET TO MINIMUM RATE ON (B)(6) 2014 UNTIL THE CATHETER REPLACEMENT OCCURS.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PUMP ROTATING CAUSED A KINK IN POCKET. THE PATIENT APPEARED TO BE THE CAUSE OF THE PUMP ROTATION. THE PROXIMAL PART OF THE CATHETER WAS REPLACED. AT THE TIME OF REPORT THE PATIENT WAS GETTING GOOD RELIEF AND DOING WELL.

    Description of Event or Problem · 1

    IT WAS CLARIFIED THAT THE PUMP TURNED MULTIPLE TIMES CAUSING THE CATHETER TO KINK. THE SEPTUM WAS NEVER FACING THE BODY WHEN THE PATIENT WAS EXAMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460778 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention