BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2911419 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-00485
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    December 15, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE PATIENT'S PUMP WAS ALARMING EVERY HOUR. THE PATIENT SHOULD HAVE HAD A PUMP REFILL ON (B)(4) 2012. THEREFORE, IT WAS CLEAR THE LOW VOLUME ALARM WAS GOING OFF. HE NEEDED A REFILL. PATIENT WAS UNSURE IF THE ALARM HAD BEEN GOING FOR ONE DAY OR LONGER. HCP DECIDED TO EXPEDITE A REFILL OF HIS PUMP. THE HCP CALLED THE PATIENT AND THE HOSPITAL PHARMACY HE USUALLY HAS HIS REFILLS IN. ORDERS WERE FAXED AND THE HCP WAS ALERTED LATER THAT AFTERNOON THAT THE MEDICATION HAD BEEN MIXED. THE PATIENT HAD A REFILL OF THIS PUMP ON (B)(6) 2012 AT (B)(6) HOSPITAL (B)(6). THIS WAS DONE ON A SEMI-URGENT BASIS ON A SATURDAY AFTERNOON. THE PATIENT'S REGULARLY SCHEDULED REFILL HAD NOT BEEN SCHEDULED BY THE HCP'S OFFICE. PATIENT CALLED REPORTING THAT HIS PUMP WAS BEEPING IN THE MORNING AT 9:54 AM. THE HCP MADE ARRANGEMENTS TO HAVE HIS MEDICATIONS PREPARED AT THE SAME HOSPITAL PHARMACY THAT NORMALLY MAKES HIS MEDICATIONS AND PERFORMED A ROUTINE REFILL AT 230 PM TO 245 PM IN THE HOSPITAL ED. PRINT OUTS WERE MADE AND RETAINED. THEY CONFIRM NO CHANGE IN RATE WAS MADE AT THE TIME OF THE REFILL. PATIENT LEFT THE HOSPITAL ABOUT 250 PM . PATIENT WAS TRANSPORTED BY A FRIEND TO A RESIDENCE ABOUT 30 MILES FROM (B)(4). PATIENT WALKED OUT OF THE CAR BY HIMSELF TO THE FRIEND'S GARAGE SO THAT THEY COULD SWEEP THE FLOOR AND CLEAN UP WHEN THE PATIENT REPORTED RAPID ONSET IN A MATTER OF A FEW MINUTES OF ASCENDING NUMBNESS FROM HIS FEET, TO HIS ABDOMEN. HE FIRST NOTICED THAT HIS ABDOMEN WAS NUMB, THAT HE COULD NOT FEEL THE COLD IN THE GARAGE. HE TRIED TO MAKE IT FROM THE ATTACHED GARAGE INTO THE HOUSE BUT WAS UNABLE TO DO SO. HE USED HIS CELL PHONE TO CALL HIS FRIEND WHO WAS NOW IN THE HOUSE. HE TOLD HIS FRIEND TO CALL AN AMBULANCE URGENTLY AND ASKED TO BE HELPED INTO THE HOUSE. HE WAS ABLE TO WALK WITH ASSISTANCE TO THE HOUSE BUT REPORTED HE COULD NOT STRAIGHTEN UP. WHEN HE REACHED THE HOUSE, HE WAS UNABLE TO STAND UP AND WENT TO THE FLOOR. HE REPORTS HE LOST USE OF HIS LEGS. THE AMBULANCE ARRIVED AND PATIENT WAS VERY WEAK BUT ABLE TO TALK. THE EMT WERE TREATING HIM IN A ROUTINE MANNER. THE PATIENT INSISTED THAT HE WAS IN DANGER OF DYING AND REQUESTED URGENT TRANSPORT. THE PATIENT ASKED HIS FRIEND TO CALL THE HCP'S CELL PHONE WHICH HE DID. PATIENT ESTIMATES THAT THE TIME FRAME BETWEEN NOTING PROBLEMS, CALLING 911 AND THE AMBULANCE ARRIVING WAS APPROXIMATELY 15 MINUTES. THEREFORE, THE ONSET OF SYMPTOMS WAS AT APPROXIMATELY 5:12 PM. THIS IS A 2 HOUR AND 21 MINUTE TIME FRAME FROM WHEN HE LEFT THE HOSPITAL. THE HCP LISTENED TO THE SITUATION, TALKED TO THE EMT, INFORMED THEM THEY WERE DEALING WITH A LIFE AND DEATH SITUATION OF PROBABLE LOCAL ANESTHETIC OVERDOSE, REQUESTED ALL RESUSCITATIVE MEASURES BE AVAILABLE AND USED INCLUDING INTUBATION AND CARDIAC SUPPORT AND THAT EMERGENCY RAPID TRANSPORT TO THE HOSPITAL BE UNDERTAKEN. THE HCP ADVISED TO NOT USE TRENDELENBURG AND START AN IV. THIS TRIP WAS ESTIMATED TO REQUIRE 20 MINUTES. THE PATIENT REPORTED TO THE HCP HE WAS NUMB UP TO HIS STERNUM, COULD NOT EFFECTIVELY USE HIS ARMS OR HIS TRUNK MUSCLES, THAT HE PASSED OUT TWICE, REMEMBERS BEING GIVEN NARCAN, THIS MADE HIM FEEL LIKE HE WAS HAVING A HEART ATTACK. THE PATIENT ARRIVED, WAS CONSCIOUS BUT SEDATED, HYPOTENSIVE, BRADYCARDIC WITH SOME ARRYTHMIA AS. HE HAD RECEIVED 2 MG OF NARCAN WHICH HAD IMPROVED HIS MENTAL STATUS AND RESPIRATORY RATE BUT HE WAS STILL SOMEWHAT SEDATED ALTHOUGH HE WAS ABLE TO COMMUNICATE. HE COULD NOT MOVE OR FEEL HIS LEGS. HE REPORTED NUMBNESS TO HIS NIPPLES. HE SAID IT HAD BEEN WORSE IN THE AMBULANCE AND THAT HE HAD FELT NUMBNESS UP TO HIS NECK. HE COULD MOVE HIS ARMS BUT THEY WERE WEAK. HE COULD NOT MAINTAIN NORMAL TRUNK POSTURE AND WOULD SLIDE OFF TO HIS LEFT ON THE STRETCHER. HE WAS HAVING SPASTIC JERKING EVERY MINUTE OR SO OF HIS UPPER BODY. HE WAS HAVING SOME RHYTHM IRREGULARITIES, MOSTLY PVC AND BRADYCARDIA. THE PUMP WAS INTERROGATED, SET TO MINIMUM RATE, THE LOG WAS INTERROGATED, NO INDICATION OF PUMP MALFUNCTION, CHANGE FROM BASELINE RATE, BOLUS WAS DETECTED. THE PUMP POCKET APPEARED NORMAL. WHILE THE PATIENT WAS IN THE ED, WITHIN ONE HOUR HE HAD COMPLETE RESOLUTION OF NUMBNESS IN HIS CHEST, ABDOMEN, AND LOWER EXTREMITIES. HE WENT FROM UNABLE TO MOVE HIS LOWER EXTREMITIES TO ABLE TO MOVE ON COMMAND AND NORMALLY. HIS MENTAL STATUS RETURNED TO NORMAL. THE PATIENT WAS ADMITTED TO CCU AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED THE NEXT MORNING, 12/16/12. THE HCP BELIEVED THE PATIENT HAD SYMPTOMS CONSISTENT WITH AN ACUTE BOLUS OF LOCAL ANESTHETIC ABOUT 2 HOURS AND 20 MINUTES AFTER HIS PUMP REFILL. THE LOCAL ANESTHETIC EFFECT APPEARED ACUTELY AFTER A PUMP REFILL AND RESOLVED QUICKLY, WITHIN AN HOUR AND A HALF OF ONSET. THIS SUGGEST THAT THE DOSE WAS NOT IN THE ORDER OF 20 MG. EVEN ALLOWING FOR PATIENT TOLERANCE OVER TIME TO LOCAL ANESTHETIC. THE PUMP DID NOT RECORD EVIDENCE OF MALFUNCTION. THE PUMP REFILL WAS CORRECTLY PLACED. IF THE HCP INJECTED 42 MLS INTO THE RESERVOIR, THEN THE MAXIMUM MISSING VOLUME IS 1.0 ML OR 11 MG OF MARCAINE. THIS IS THE MAXIMUM BOLUS DOSE ANY UNDER CIRCUMSTANCES HE COULD HAVE RECEIVED. THERE WAS NO OBVIOUS VOLUME DEFICIENCY IN THE RESERVOIR. THE HCP ALSO INDICATED THAT THERE WAS A FACTUAL PROBABILITY THAT A SMALL AMOUNT OF FLUID FROM THE RESERVOIR WAS BOLUSED INTO HIS SPINAL FLUID AT AROUND 5 PM. IF EVEN 0.1 MLS OF FLUID WAS BOLUSED THIS WOULD BE 3.38 MG OF MARCAINE. THE MOST HE COULD HAVE RECEIVED WOULD BE 1 ML OR 34 MG OF MARCAINE. THE HCP DID NOT THINK HE RECEIVED THIS MUCH AS IT WOULD HAVE TAKEN HOURS FOR THIS TO WEAR OFF AND PROBABLY WOULD HAVE BEEN LETHAL TO HIM. GIVEN QUICK OFFSET AND IGNORING ANY TOLERANCE EFFECTS HE MAY HAVE RECEIVED 4 MG OF MARCAINE. IF TOLERANCE IS PRESENT HE COULD HAVE RECEIVED 8-10 MG OF MARCAINE. THEREFORE THE MAXIMUM VOLUME THE HCP BELIEVED THE PATIENT RECEIVED WOULD BE 0.3 MLS AND THE RANGE WOULD BE 0.1 MLS TO 0.3 MLS. IF THIS WAS HYPOBARIC AND ASCENDED IN HIS SPINAL FLUID HE WOULD NOTE QUICK ONSET OF LOCAL ANESTHETIC EFFECT. HE WOULD ALSO NOTE FAIRLY QUICK OFFSET. HE WOULD ALSO RECEIVE AN ADDITIONAL DOSE OF MORPHINE WHICH WOULD CONTRIBUTE ON AN ACUTE BASIS TO URINARY RETENTION. THE PUMP DELIVERED MORPHINE, BUPIVACAINE, CLONIDINE, AND BACLOFEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DRUG TESTING CONFIRMED THAT THE CONCENTRATIONS DID NOT CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16725 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Hospitalization| R