BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 2990091 · Received March 5, 2013

    Report

    Report Number
    6000030-2013-00048
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT # L55028, IMPLANTED: (B)(6) 1999, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PUMP STARTED TO BEEP ABOUT TEN DAYS PRIOR TO THE DATE OF THIS REPORT. THE PATIENT WAS SEEN IN A PHYSICIAN'S OFFICE AND CHANGES WERE MADE TO STOP THE BEEPING. HOWEVER, IT WAS UNDETERMINED IF THE BEEPING WAS DUE TO A LOW RESERVOIR OR LOW BATTERY AS THE PATIENT HAD MISSED A REFILL APPOINTMENT AND THE PUMP HAD BEEN IMPLANTED FOR OVER NINE YEARS. IN THE PAST, THIS PUMP HAD ALWAYS GIVEN BACK THE VOLUME IT WAS SUPPOSED TO GIVE. THE PUMP WAS INTERROGATED A FEW DAYS PRIOR TO THE DATE OF THIS REPORT AND THERE WAS NO EVIDENCE OF A LOW RESERVOIR ALARM AND THE PATIENT NO LONGER HEARD THE BEEPING. THE PATIENT AND FAMILY LATER REPORTED THAT THEY THOUGHT THE DEVICE MALFUNCTIONED. THEY DID NOT WANT THE PUMP REFILLED OR REPLACED AND WANTED THE PUMP TURNED OFF COMPLETELY. IT WAS REPORTED THAT THE PATIENT'S STOMACH "WAS GROSSLY WHEN SHE WAS BLOWING UP AND PULLING ON THAT CATHETER." IN ADDITION, THE PATIENT HAD EXPERIENCED SWELLING, PAIN, AND GOT "SICK, FLU-LIKE" FOR A WEEK OR SO AFTER THE LAST COUPLE REFILLS. THE PUMP WAS SUCCESSFULLY INTERROGATED AGAIN ON THE DATE OF THIS REPORT. TROUBLESHOOTING AND OPTIONS WERE DISCUSSED BETWEEN THE PHYSICIAN, PATIENT, AND THE PATIENT'S SPOUSE. THIS DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WAS TRYING TO HELP THE PATIENT FIND A PROVIDER WHO WOULD REMOVE THE DEVICE AS THE IMPLANTING HCP WAS ¿NOT WILLING TO TAKE IT OUT ANYMORE OR HE DOESN¿T LIKE TO DO THOSE SURGERIES.¿ THE HCP WASN¿T ¿ENTIRELY SURE¿ WHY THE PATIENT WANTED HER DEVICE REMOVED BUT THOUGHT IT WAS NOT WORKING FOR HER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NOTHING WRONG WITH THE DEVICE. THE PATIENT WAS DUE TO BE REFILLED ON (B)(6) 2013 BUT SKIPPED THE REFILL AND THE PUMP ALARMED. THE PATIENT FINALLY CAME INTO THE HEALTH CARE PROVIDER¿S (HCP) OFFICE ON (B)(6) 2013 AND AT THE TIME REFUSED TO HAVE THE PUMP REFILLED. THE HCP FILLED THE PUMP WITH SALINE. IT WAS NOTED THE PATIENT MOVED AWAY AND WAS COMING BACK AND FORTH TO THE HCP BUT WAS HAVING A HARD TIME GETTING BACK. THE HCP TOLD THE PATIENT TO FOLLOW UP WITH THEIR FAMILY DOCTOR TO FIND A CLOSER HCP. THE MANAGING HCP DID NOT HEAR BACK FROM THE PATIENT AGAIN UNTIL (B)(6) 2013 BECAUSE SHE HAD INCREASED PAIN. THE PATIENT WAS SEEN ON (B)(6) 2013 AND THE PATIENT DID NOT MENTION ANYTHING TO THE HCP ABOUT WANTING THE PUMP REMOVED. THE PUMP STILL HAD SALINE AT THE VISIT AND UPON INTERROGATION THE PUMP WAS WORKING FINE. THE HCP AGAIN PROVIDED CONTACT INFORMATION TO THE PATIENT AND SHE WAS SENT BACK TO HER FAMILY DOCTOR. THE HCP HAD THOUGHT THE PATIENT WOULD GO TO A MEDICAL CENTER CLOSER TO HER HOME BUT SHE HAD REPORTEDLY NEVER GONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94306 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1