BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3230080 · Received July 16, 2013

    Report

    Report Number
    3007566237-2013-02366
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER; PRODUCT ID 8780, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER; PRODUCT ID 8781, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER; PRODUCT ID 8780, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL/CORRECTED INFORMATION: PRODUCT ID: 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. ADDITIONAL/CORRECTED INFORMATION: THE CORRECT MANUFACTURING SITE NUMBER IS SITE # (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER SERIAL # (B)(4) REVEALED THAT DIFFICULTY WITH THE SUTURELESS CONNECTOR LED TO EXPLANT. THE CATHETER TO CATHETER CONNECTER HAD BOTH COLLETS SECURELY AND PROPERLY ATTACHED. THE OCCLUSION NOTED IN THE CATHETER WAS NOT MANUFACTURING RELATED. ANALYSIS OF CATHETER SERIAL # (B)(4) REVEALED THAT THE CATHETER WAS TORN OR BROKEN AT OR AFTER EXPLANT. THIS DID NOT AFFECT INFUSION. THE END OF THE CATHETER PORTION ATTACHED TO ONE END WAS NOT A CLEAN CUT, BUT INSTEAD WAS JAGGED OR ROUGH LOOKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WEEK AGO THE SPINAL SEGMENT OF THE CATHETER WAS IMPLANTED FOR A TRIAL. THE PATIENT HAD A SUCCESSFUL TRIAL. ON (B)(6) 2013, THEY WERE IMPLANTING THE PUMP SEGMENT OF CATHETER AND THE PUMP. THEY DIDN'T REOPEN THE PATIENT'S BACK INCISION; THEY CUT OFF 27 CM OF THE EXISTING CATHETER AND WERE CONNECTING A NEW PUMP SEGMENT TO THE EXISTING CATHETER. THE COLLET CAME OFF OF THE FIRST 8780 THAT THEY TRIED; THEY WERE TRYING TO CLICK IT ON AND IT DISCONNECTED/CAME APART AND FELL AWAY. THE PHYSICIAN FELT IT WAS COMPROMISED SO A SECOND 8780 WAS USED AND IT WORKED FINE. THAT CATHETER WAS THEN ATTACHED TO THE PUMP, THEY TRIED TO DISCONNECT IT TO CHECK FLOW AGAIN AND IT WOULDN'T COME OFF OF THE PUMP. IT EVENTUALLY CAME OFF OF THE PUMP, BUT THE WHOLE SILICONE PIECE CAME OFF AND ONLY METAL WAS LEFT. THEY USED MOSQUITO CLIPS TO GET IT OFF THE PUMP AND THEN USED THE PUMP SEGMENT OF AN 8781 SO THEY WOULD HAVE A NEW PUMP CONNECTOR. PRIOR TO ATTACHING THE COMPLETE CATHETER TO THE PUMP, THEY HAD LIGHT FLUID LOW. AFTER ATTACHING THE CATHETER TO THE PUMP, THE PHYSICIAN COULD PUSH SALINE THROUGH THE SIDE PORT WITH THE CAP (CATHETER ACCESS PORT) KIT NEEDLE, BUT THEY COULDN'T ASPIRATE. THEY OPENED ANOTHER CAP KIT TO USE A DIFFERENT NEEDLE. THEY ALSO TRIED DISCONNECTING THE CATHETER FROM THE PUMP AND ASPIRATING THROUGH THE SUTURELESS CONNECTOR. A DYE STUDY WAS DONE AND THEY DETERMINED THAT THERE WAS AN ISSUE WITH THE SPINAL SEGMENT OF THE CATHETER. THEY DECIDED TO REPLACE THE ENTIRE CATHETER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE PATIENT WAS DOING WELL AND RECEIVING THERAPY WITH NO ISSUES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328399 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR