BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3220905 · Received July 11, 2013

    Report

    Report Number
    3004209178-2013-11615
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 12, 2013
    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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8575, LOT# J0455495R, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8575, LOT# J0455495R, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CATHETER HAD ONLY BEEN DISCONNECTED AND NOT CUT. THE PHYSICIAN HAD BEEN UNABLE TO DETERMINE WHAT CAUSED IT, BUT THE LITHOTRIPSY PROCEDURE WAS SUSPECTED. NO HOLES WERE SEEN IN THE CATHETER AND THERE HAD NOT BEEN ANY ISSUE WITH THE PIN OR THE SUTURING. IT WAS INDICATED THAT THE PUMP HAD BEEN DRY DUE TO THE PATIENT HAVING A LOT OF UNRELATED MEDICAL ISSUES AND HE NEEDED A TRANSPORT TO GET TO APPOINTMENTS. THE SURGERY TO RECONNECT THE CATHETER WAS SUPPOSED TO HAPPEN PRIOR TO HIS REFILL DATE, BUT THE PATIENT HAD OTHER MEDICAL AND TRANSPORTATION ISSUES THAT DID NOT ALLOW HIM TO COME TO THE SURGERY APPOINTMENT. BY THE TIME THE SURGERY OCCURRED, THE REFILL DATE HAD PASSED AND THE PUMP WAS DRY. IT WAS DECIDED TO REPLACE THE PUMP, THOUGH THERE HAD BEEN NO DEVICE ISSUE BESIDES IT RUNNING DRY. IT WAS REPORTED THAT THE CAUSE OF THE POST-SURGICAL COMPLICATIONS WAS AN ALLERGIC REACTION TO THE ANESTHESIA MEDICATION THAT WAS USED. IT WAS NOTED THAT THAT WAS THE ONLY PLAUSIBLE EXPLANATION THE PHYSICIAN COULD COME UP WITH.

    Description of Event or Problem · 1

    IT WAS REPORTED A BROKEN CATHETER OCCURRED AND THERE WAS ¿PATIENT TRAUMA¿ AFTER THE CASE. IT WAS NOTED ¿NOT NECESSARILY DUE TO PUMP¿. A DISCONNECT AT THE PUMP CONNECTOR OCCURRED WHICH RESULTED IN EXPLANT AND REPLACEMENT. THE PATIENT CODED AFTER THE SURGERY, WAS RESUSCITATED AND WAS THEN SENT TO SHOCK TRAUMA INTENSIVE CARE UNIT (ICU). THE HEALTH CARE PROVIDER (HCP) STOPPED THE PUMP BOLUS THAT WAS INITIATED AFTER THE SURGERY AND SET THE PUMP TO MINIMUM RATE MODE. IT WAS NOTED THE BOLUS WAS NOT COMPLETE. THE HCP ¿FELT CERTAIN¿ THE PATIENT DID NOT GO INTO SHOCK BECAUSE OF THE BACLOFEN BUT THE ROOM FULL OF STAFF HAD FELT IT SHOULD BE STOPPED. THE HCP ALSO REPORTEDLY DECIDED TO REPLACE THE CATHETER THAT WAS DISCONNECTED FROM THE PUMP BECAUSE THE CONCENTRATION WAS TO BE DIFFERENT WHEN THE NEW PUMP WAS HOOKED UP. THE OLD CONCENTRATION WAS 2000MCG/ML AND THE NEW CONCENTRATION WAS 500MCG/ML. DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS NOT REQUIRED. IT WAS REPORTED IT WAS BELIEVED THE PATIENT HAD NO LONGER BEEN RECEIVING ANY BACLOFEN AS THE PUMP HAD RUN DRY. THE PUMP WAS REPLACED AS A MEDICAL DECISION BY THE HEALTH CARE PROVIDER. IT WAS NOTED THE PUMP HAD BEEN EMPTY FOR AN UNKNOWN LENGTH OF TIME. IT WAS FURTHER REPORTED ¿SOMETIME¿ IN THE LAST FEW MONTHS THE PATIENT HAD LITHOTRIPSY FOR KIDNEY STONES AND WHEN AN X -RAY WAS TAKEN FOR THE KIDNEYS, IT WAS FOUND THAT THE CATHETER WAS NO LONGER CONNECTED TO THE PUMP. DURING THE SURGERY, THE OLD PRODUCT WAS REMOVED AND REPLACED WITHOUT ANY PROBLEMS. THE PATIENT WAS THEN PLACED SUPINE AFTER THE PUMP WAS UPDATED FOR A NEW IMPLANT OF 500MCG/ML CONCENTRATION AT 100MCG/DAY WHEN HE STOPPED BREATHING. IT WAS NOTED A CRASH CART WAS IN THE ROOM. IT WAS REPORTED THE PATIENT WAS SAID TO HAVE RED MAN SYNDROME, ¿WHEN UNCOVERING PATIENT HE WAS FLUSH RED ALL OVER. IT APPEARED TO BE LIKE WHEN YOU HAVE A REACTION TO SOMETHING, LIKE AN ALLERGY, ETC¿. THE LOCATION OF THE ISSUE WAS THE DEVICE POCKET. THE NEUROSURGERY RESIDENT WHO HAD WORKED ON THE PATIENT THE SAME DAY INDICATED THE PATIENT WAS OKAY. IT WAS THEN REPORTED; THE HCP HAD DECIDED NOT TO DO A BOLUS AND HAD REPLACED THE PUMP. IT WAS ALSO NOTED ¿THERE WAS MENTION OF CATHETER BREAK IN THE BACK BUT WAS UNCLEAR AND BECAME MOOT ONCE HE DECIDED NOT TO SPLICE CATHETER, BOLUS CATHETER AND INSTEAD PULL OUT¿. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN. IT WAS LATER REPORTED PRIOR TO THE REPLACEMENT THE PUMP HAD BEEN ALARMING, DUE TO THE PREVIOUSLY REPORTED EMPTY RESERVOIR. IT WAS ALSO REPORTED THE CATHETER WAS ¿CUT¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321111 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R