SYNCHROMED II
Report
- Report Number
- 3004209178-2014-12510
- Event Type
- Malfunction
- Date Received
- July 3, 2014
- Report Date
- July 25, 2016
- 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).
CONCLUSION CODE IS NO LONGER APPLICABLE FOR THIS EVENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CONCOMITANT PRODUCTS: PRODUCT ID: NEU_UNKNOWN_PROG, PRODUCT TYPE: PROGRAMMER, PHYSICIAN.
(B)(4)
THE PATIENT REPORTED THEY WERE UNDER THE IMPRESSION THAT THEY HAD 1 MONTH ON THEIR BATTERY. THE PATIENT STATED THAT THEY KIND OF KNOW THAT LAST MONTH AND THE HCP (HEALTH CARE PROVIDER) WAS SUPPOSED TO BE WORKING ON GETTING THE PATIENT IN FOR ANOTHER PUMP AS IT JUST CAME TO THEIR KNOWLEDGE THAT THE PATIENT¿S INSURANCE DIDN¿T WORK WITH THE HOSPITALS THAT THE PATIENT¿S HCP WORKS WITH. PER THE PATIENT IN THE MEANTIME THEY WERE GOING TO HAVE A PROBLEM. THE PATIENT THOUGHT THAT FOR THE LAST 2 MONTHS THE ESTIMATED ERI SHOWED 1 MONTH. THE PATIENT STATED THEY DID KNOW EXACTLY ONE MONTH AGO ON THE DAY OF THE REPORT IT SHOWED 1 MONTH AND STATED THAT IT WAS POSSIBLE TO SHOW ONE MONTH ERI MORE THAN 1 MONTH IN A ROW. THE HCP TOLD HER IT WAS 2 MONTHS AGO AND IT SHOWED THE ESTIMATED ERI WAS 1 MONTH AND THE ESTIMATED WAS 1 MONTH AFTERWARDS. IT SHOWED (B)(6) 2014 WAS THE LAST EXAMINATION, LAST CHANGE DATE (B)(6) 2014. THE PATIENT STATED THE LAST TIME THEY DID A REFILL THEY DID A CHANGE TO THE MEDICATION TO SEE IF IT WOULD HELP BECAUSE THE PATIENT INITIALLY HAD CERVICAL SURGERY AND EVEN THOUGH EVERYONE TOLD THE PATIENT THEY WERE FINE, THE PATIENT DID TEN TRIPS TO ER IN TEN DAYS AND THE PATIENT HAD A BROKEN SCREW THAT WAS CONFIRMED WITH AN X-RAY. THE PATIENT WAS ON ¿200 MICS OF FENTANYL¿ AND ALSO ¿ON THE SUCKERS¿ AND WENT SEEKING HELP. THE PATIENT THEN STATED LET¿S BACK UP, SHE WAS ON NO MEDICATION AND WAS TOLD SHE NEEDED DRUG THERAPY, THAT SHE WAS AN ADDICT BECAUSE SHE WAS HURTING. THE PATIENT STATED THE PAIN GOT SO BAD, THAT WHEN NIGHTTIME CAME SHE COULDN¿T BE IN BED, COULDN¿T SLEEP, COULDN¿T WATCH TV, THE PATIENT WAS MISERABLE. FINALLY WHEN NO ONE WOULD HELP HER SHE STARTED GOING TO ER AND WITH TEN TRIPS TO ER IN TEN DAYS. THE ER DOCTOR OFFERED HER AN X-RAY IN EXCHANGE FOR A DRUG TEST AND THAT IS WHEN IT WAS DISCOVERED THE PATIENT HAD BROKEN SCREWS AND THAT WAS WHEN THEY STARTED GIVING THE PATIENT MEDICATIONS. THAT WAS WHEN SHE WAS ON ¿200 MICS OF FENTANYL AND THE SUCKERS¿. THE PATIENT WAS TOLERANT TO THE DRUGS AND DIDN¿T THINK THEY EVER GOT A GREAT DEAL OF HELP TO BE HONEST, FELT LIKE EVERY DAY WAS A STRUGGLE AND THEN THE PATIENT¿S DAUGHTER WHOSE A PHARMACIST WHO TOLD THE PATIENT ABOUT THE PAIN PUMP, AND TOLD THE PATIENT THAT THEY WOULD BE DEAD IF THEY DIDN¿T DO SOMETHING DIFFERENT. THE PATIENT HAD A COUPLE OF HOMES IN DIFFERENT STATES AND THE PATIENT FAILED IN BOTH STATES AND WAS TOLD THE PUMPS WEREN¿T GOOD OPTIONS AND CATHETER TIPS GET CLOGGED AND BAD THINGS HAVE HAPPENED. THE PATIENT STATED THAT DIDN¿T MATTER TO HER SHE NEEDED TO FIND A DIFFERENT OPTION BECAUSE SHE WASN¿T LIVING. THE PATIENT WENT TO SEE A SICK FAMILY MEMBER AND WAS SEEING A TX HCP WHO WAS SUPPOSED TO KEEP HER IN MEDICATION UNTIL SHE WENT HOME AND ENDED UP STAYING A YEAR DOING DIFFERENT TESTS OVER A YEAR AND WAS HELPING THE PATIENT IMMENSELY FOR 3 YEARS (ON SMALL DOSE OF MORPHINE THINKS IT WAS 6 MG). THE PATIENT ONLY HAD TO HAVE IT FILLED EVERY 3-4 MONTHS AND BREAKTHROUGH MED OF LORATABS AND DID REALLY WELL FOR ABOUT THREE YEARS UNTIL THE PATIENT¿S LOWER SPINE STARTED GIVING HER PROBLEMS AND NOW HAS TO GET SURGERY ON THEIR LOWER BACK. THE PATIENT¿S BACK IS SO BAD, THE PUMP ISN¿T HELPING IT, ONCE THEY LEAVE ¿YOU SCREWED UP SURGICALLY AND EVERYONE TELLS YOUR FINE AND LEAVES THE PATIENT IN A TERRIBLE POSITION AND THINKS YOU LIVE WITH IT AS LONG AS SHE POSSIBLY CAN AND IS LOOKING FOR A GOOD SURGEON BEFORE SHE DEDICATES HERSELF TO THE SURGERY¿. THE PATIENT ALSO STATED THEY HAVE SOMETHING COLLAPSED (DISC), SCAR TISSUE FORMING OVER AND WHY THE PATIENT HAS SCIATICA AND EVERYTHING ELSE THAT IS VERY, VERY BAD. THE PATIENT WAS GETTING HELP WITH INJECTIONS FOR HER BACK BUT NOT HELPING HER LEGS AND NOW ISN¿T GETTING ANY RELIEF IN HER BACK AND NOW IS AT POINT TO DO SURGERY. THE PATIENT WAS TERRIFIED SHE IS STILL GOING TO BE AT SAME PLACE WITH HER NECK, IF HER PUMP STOPS ON HER SHE WILL BE RIGHT BACK WHERE SHE WAS WITH HER NECK AND IS THE WORST THING SHE CAN IMAGINE. THE PATIENT KNOW SHE WILL BE IN THE SAME POSITION BECAUSE WHEN THEY CHANGED FROM MORPHINE (SMALLER DOSE) TO THE FENTANYL THE PATIENT COULD STILL FEEL THE SENSATION FROM THE PAIN IN THE NECK. PER THE PATIENT IT FEELS LIKE A COUPLE OF FINGERS ARE JABBING HER WHERE HER WINDPIPE IS, LIKE SHE CAN¿T BREATHE EVEN THOUGH SHE CAN. THE PATIENT ALSO STATED SHE FEELS LIKE SHE IS BEING HUNG WITH A ROPE AROUND HER NECK. THE PATIENT WAS AFRAID IF HER PUMP STOPS ON HER SHE IS GOING TO BE IN TROUBLE. THE PATIENT DID TRY TO GET THE NURSE TO GO BACK AND LOOK BECAUSE THE PATIENT WAS PRETTY SURE THAT THE TIME BEFORE THIS ESTIMATED WAS ONE MONTH AND THE NURSE TOLD THE PATIENT NO IT WAS TWO. THE PATIENT PLANNED TO CALL NURSE BACK AND LOOK THROUGH HER RECORDS AND SEE HOW MANY MONTHS SHE HAS BEEN LOOKING AT ONE MONTH. THE PATIENT STATED THEY SHOULD HAVE NEVER GOTTEN THIS LOW BECAUSE THE PATIENT IS OUT OF NETWORK THERE BECAUSE THE INSURANCE COMPANY SHE IS WITH IS DIDN¿T HAVE ANYBODY IN NETWORK THAT COULD DO THE PUMP. THE PATIENT STAYED WITH HER HCP WHO HAD BEEN WITH LAST INSURANCE COMPANY THE PATIENT WAS WITH WHO WENT OUT OF BUSINESS STATING THAT INSURANCE COMPANY DIDN¿T HAVE A DOCTOR IN THE NETWORK AND WAS OUT OF NETWORK WITH THEM ALSO. THE PATIENT WAS ALSO OUT OF NETWORK THE HOSPITALS THAT THE HCP DOES SURGERY OUT OF NEITHER ONE OF THEM WILL TAKE THE PATIENT¿S INSURANCE, WHICH DOESN¿T MAKE SENSE TO PATIENT. THE PATIENT DROVE OVER 40 MILES TO SEE THEIR HCP AND WAS LOOKING FOR A NEW HCP. THE PUMP WAS USED TO DELIVER FENTANYL IT WAS LATER REPORTED THAT THE PUMP BATTERY WAS LOW AND THE PATIENT THOUGHT THAT IT WAS TURNED OFF. A WEEK AGO, THE PATIENT HAD GONE TO THE HCP¿S (HEALTHCARE PROVIDER¿S) OFFICE AND THEY REDUCED THE MEDICATION TO HALF AND TOLD HER TO COME BACK (B)(6) 2014 TO TURN IT OFF. ON (B)(6) 2014, THE HCP PUT SALINE IN IT ¿AND WENT TO READ IT BUT COULD NOT GET ANY READING OUT OF IT¿. THE PATIENT HAD A REPORT, BUT SHE DID NOT THINK THE ERI (ELECTIVE REPLACEMENT INDICATOR) DATE WAS ON THE REPORT. THE PATIENT WANTED TO KNOW IF HER PUMP WAS ¿DEAD OR NOT¿. THE HCP TOLD THE PATIENT THAT THE PUMP WOULD NOT READ BECAUSE IT MAY BE DEAD. THE PATIENT THOUGHT SHE HAD MONTHS TO DEAL WITH THIS. THE PATIENT WAS TOLD IT WAS (B)(6) FOR ERI. THE PATIENT FELT THAT THEY EMPTIED THE PUMP AND PUT SALINE IN IT FOR NOTHING. THE PATIENT WAS WONDERING IF THE SALINE COULD BE CHANGED BACK TO MEDICATION. THE PATIENT DIDN¿T KNOW IF SHE WAS HAVING THE PUMP REPLACED. THE PATIENT STATED THAT THE HCP DID NOT SEEM TO KNOW IF THE PUMP WAS DEAD; SHE WAS TRYING TO FIGURE OUT IF THE PUMP WAS DEAD. THE PATIENT STATED THE ¿HCP WAS GUESSING IF PUMP IS DEAD AND IT DOESN¿T SHOW NEW MEDICATION IT DOES NOT RESPOND¿. THE PATIENT HAD BEEN IN THE HOSPITAL A COUPLE OF WEEKS AGO WITH PNEUMONIA ¿AND WASN¿T SURE WHAT WAS HAPPENING WITH THE PUMP BECAUSE SHE WAS IN SO MUCH PAIN". THE PUMP WAS READ WHILE THE PATIENT WAS IN THE HOSPITAL. THE PATIENT WAS TOLD AT THAT TIME THAT THE PUMP WAS AT ERI WHICH MEANT THAT THE BATTERY WAS GOING TO DIE; THE PATIENT WAS TOLD THAT SHE HAD UNTIL SEPTEMBER TO HAVE THE PUMP REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT PREVIOUSLY RECEIVING FENTANYL (600 MCG/ML AT 80 MCG/DAY) VIA AN IMPLANTED PUMP. ON (B)(6) 2016 IT WAS REPORTED THAT THE HCP WAS SEEING THE PATIENT FOR THE FIRST TIME TODAY AND MAY BE TAKING OVER THE CARE OF THE INFUSION SYSTEM. THE HCP WAS NOT SURE WHO PREVIOUSLY MANAGED THE PATIENT. A PUMP ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. ON (B)(6) 2014 THE PUMP LOGS INDICATED "EMPTY RESERVOIR ALARM\"; ON (B)(6) 2014 "EOS (END OF SERVICE)" OCCURRED; AND ON (B)(6) 2014 A "STOPPED PUMP PERIOD MAY EXCEED TUBE SET" WAS RECORDED. THE HCP DID NOT KNOW THE HISTORY OF THE ALARMS THAT OCCURRED IN 2014. NO PATIENT SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 389590 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR |