BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3193168 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10969
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2380-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE 8709SC CATHETER H865905613 REVEALED A DRIED DRUG OR BLOOD OCCLUSION IN THE CATHETER BODY. ONLY THE PROXIMAL PORTION OF THE SC CATHETER WAS RETURNED. INITIAL PATENCY TESTING SHOWED THE SEGMENT WAS OCCLUDED. THE CATHETER WAS CUT ONCE TO TROUBLESHOOT WHERE THE OCCLUSION WAS AND IT WAS FOUND TO BE IN THE METAL PIN CONNECTOR. THE OCCLUSION WAS ABLE TO BE BROKEN LOOSE AND WAS NOT RELATED TO THE MANUFACTURE OF THE CATHETER. THE SC CONNECTOR WAS CLOSELY INSPECTED FOR POTENTIAL EVIDENCE OF DETACHMENT, SPECIFICALLY EACH RETAINING RING FINGER. BOTH RETAINING RING FINGERS DID SHOW SLIGHT MARKS ON THEM BUT THESE WERE MOST LIKELY CAUSED DURING THE EXPLANT PROCESS. THERE WERE NO OTHER MARKS ON THE RETAINING RING FINGERS THAT MIGHT INDICATE THE SC CONNECTOR WAS MISALIGNED WHILE CONNECTED TO THE PUMP¿S OUTLET PORT. THE SC CONNECTOR WAS THEN ATTACHED TO THE PRESSURE TESTER IN THE LAB AND NO LEAKING WAS SEEN IN THE AREA OF THE SC CONNECTOR. FINALLY, THE SC CONNECTOR WAS ATTACHED TO A PUMP IN THE LAB AND PRESSURIZED AIR WAS INJECTED THROUGH THE CATHETER ACCESS PORT (CAP) WHILE THE DISTAL END OF THE CATHETER WAS CLAMPED SHUT. PRESSURE WAS INCREASED TO 43 PSI AND HELD THERE FOR 30 SECONDS WHILE THE WHOLE ASSEMBLY WAS PLACED UNDER WATER. NO LEAKING WAS SEEN COMING FROM THE SC CONNECTOR. THIS SHOWS THE SC CONNECTOR WAS CAPABLE OF MAKING A ROBUST, SEALED CONNECTION TO THE OUTLET PORT OF PUMP.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A COLLECTION OF CEREBROSPINAL FLUID (CSF) IN HER ABDOMEN DUE TO A CATHETER DISCONNECTION FROM THE PUMP. THE PHYSICIAN NOTICED THE COLLECTION OF FLUID AROUND THE SUTURELESS CONNECTOR (SC) AND DECIDED TO REPLACE THE CATHETER. A NEW SC CONNECTOR WAS IMPLANTED ON 2013 (B)(6). ADDITIONAL PATIENT SYMPTOMS INCLUDED DRAINAGE AND INCISIONAL WOUND OPENING AT THE DEVICE POCKET. PATIENT OUTCOME AT THE TIME OF THE REPORT WAS UNKNOWN. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293624 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention