SYNCHROMED II
Report
- Report Number
- 3004209178-2014-11517
- Event Type
- Injury
- Date Received
- June 12, 2014
- Date of Event
- October 16, 2013
- Report Date
- September 3, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1570-2014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT# N202594, IMPLANTED (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE CATHETER. (B)(4).
(B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THE SAME RECURRING ISSUE OF OVERDOSE SYMPTOMS AND HOSPITALIZATION REQUIRING A VENTILATOR (OR NEAR NEEDING A VENTILATOR) ON (B)(6) 2013, (B)(6) 2014 (FOLLOWING A REFILL), (B)(6) 2014 (FOLLOWING A REFILL), (B)(6) 2014 (PATIENT WAS HOSPITALIZED REQUIRING A VENTILATOR AND THE PUMP WAS SET TO MINIMUM RATE MODE, SYMPTOMS CONTINUED), AND (B)(6) 2014 (PATIENT WAS HOSPITALIZED, THE PUMP WAS TURNED OFF WITH THE PUMP OFF CODE). DURING THE (B)(6) 2014 EVENT, THE PATIENT WAS IN INTENSIVE CARE AND OVERDOSED. THE EVENT OCCURRED WHEN THE PUMP WAS STOPPED. THE PUMP WAS TO BE PERMANENTLY DISABLED TO RULE IT OUT AS THE CAUSE. IT WAS NOTED THAT THE PUMP COULD BE REPLACED, BUT IF IT WAS THE ISSUE, IT WOULD HAVE CAUSED FIVE LIFE-THREATENING EVENTS. THE PUMP WAS NEVER EXPLANTED DUE TO THE LAST HOSPITALIZATION. THE HEALTHCARE PROVIDER (HCP) WANTED TO LEAVE THE PUMP IMPLANTED BECAUSE REMOVAL WAS NOT NECESSARY. THE PUMP WOULD BE REMOVED IF THE PATIENT EVER REQUIRED SURGERY IN THE AREA. THE PUMP WAS NOT TO BE REPLACED. ALL PRE-EXISTING CONDITIONS WERE RULED OUT THAT COULD EXPLAIN THE SYMPTOMS. IT WAS STATED THAT THE PATIENT HAD SEVERAL CTS. IT WAS NOTED THAT THE PATIENT HAD SPINE BIFIDA AND REQUIRED A SHUNT. THE HCP WAS SURE THAT THE ISSUE WAS WITH THE PUMP.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT DUE TO THE PAST ISSUES SURROUNDING REFILLS (OVERINFUSION HISTORY, BECOMING COMATOSE FOLLOWING REFILL), THE PATIENT WAS HOSPITALIZED ON (B)(6) 2014 AND REFILLED WITH 15ML OF GABLOFEN (2000MCG/ML) (THE PUMP WAS PREVIOUSLY USED TO DELIVER COMPOUNDED BACLOFEN AND BUPIVACAINE (4000MCG/ML), BUT IT WAS REMOVED THROUGH SYSTEM CONTENT REMOVAL). A TRACHEOTOMY WAS PERFORMED AND THE PATIENT WAS PLACED ON A VENTILATOR. IT WAS UNKNOWN IF THE PATIENT WAS TAKING ANY OTHER MEDICATION. THE RESERVOIR VOLUMES WERE ACCURATE (AS WELL AS THE PREVIOUS REFILL). THE DOSAGE WAS DECREASED FROM 580 TO 275MCG/DAY. THE PATIENT REMAINED HOSPITALIZED AND WAS DISCHARGED TWO DAYS LATER. THE PUMP WAS AT MINIMUM RATE MODE (3MCG/DAY) AT DISCHARGE. THE PATIENT DID NOT EXPERIENCE WITHDRAWAL SYMPTOMS. THE ACTUAL RESERVOIR VOLUME (ARV) AT REFILL WAS 0.2ML WITH AN EXPECTED RESERVOIR VOLUME (ERV) OF 4.8ML. DURING THE INTENSIVE CARE STAY, THE HCP ACCESSED THE CENTER PORT OF THE PUMP AND CONFIRMED ACCURATE RESERVOIR VOLUME DURING THE FIRST FEW DAYS AFTER THE REFILL. THE PATIENT HAD NO OVERINFUSION SYMPTOMS SINCE HOSPITAL DISCHARGE. THE PATIENT WAS THEN ADMITTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2014; WAS FLACCID AND UNRESPONSIVE. A TOXICOLOGY SCREEN WAS PERFORMED IN THE ER. THE HEALTHCARE PROVIDER (HCP) QUESTIONED IF THE PARENTS WERE INVOLVED WITH THE PATIENT'S SYMPTOMS. THE PATIENT HAD BEEN LIVING WITH PARENTS, BUT RECENTLY WENT INTO A "HOME." THE PUMP WAS APPROACHING END OF LIFE IN THE NEXT SEVERAL MONTHS AND THE PLAN WAS TO REPLACE THE PUMP PRIOR TO THE EMPTY RESERVOIR DATE OF (B)(6) 2014. THE PATIENT WAS SCHEDULED FOR A REPLACEMENT ON (B)(6) 2014. IT WAS NOTED THAT THE PATIENT HAD 2 CATHETERS. THE CATHETER GOES FROM THE LUMBER REGION TO THE RIGHT LOWER QUADRANT POCKET WITH A CONNECTOR AND EXTENSION TO RIGHT UPPER CHEST. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP HAD BEEN STOPPED SEVERAL MONTHS AGO AS THE PATIENT WAS WEANED (AS PREVIOUSLY REPORTED). THE PATIENT¿S FAMILY DECIDED THAT THEY WANTED TO GO AHEAD AND HAVE IT REPLACED. THE HCP DID A CATHETER ACCESS PORT (CAP) DRAW TO SEE IF THE CATHETER WAS PATENT, AND THEY WERE ABLE TO WITHDRAW OVER 2 CC OF FLUID WITH EASE. X-RAYS WERE DONE AS WELL, AND THERE WERE NO VISIBLE BREAKS OR TEARS NOTED. IT WAS NOTED THAT THE PUMP REMAINED IMPLANTED AND IN SERVICE, AND THAT REPLACEMENT WAS REQUIRED. THE ISSUE WAS RESOLVED. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE NO INJURY. THE PUMP SYSTEM WAS BEING USED TO INFUSE COMPOUNDED BACLOFEN.
IT WAS REPORTED THAT THERE WAS A VOLUME DISCREPANCY PROBLEM. THE ACTUAL RESIDUAL VOLUME (ARV) WAS LESS THAN THE EXPECTED RESIDUAL VOLUME (ERV). THE ARV WAS LESS THAN 1CC AND THE ERV WAS 5CC. IT WAS NOTED THAT THE SAME RESERVOIR VOLUME DISCREPANCY ISSUE OCCURRED TWICE, THE DAY PRIOR TO REPORT AND IN (B)(6) 2014. THE PUMP IS REFILLED EVERY 90 DAYS PER CALLER. IT WAS NOTED THAT ON (B)(6) 2013 THE VOLUME DISCREPANCY WAS WITHIN 1CC THAT WAS EXPECTED. IN (B)(6) 2014, POST PUMP REFILL THE PATIENT HAD SYMPTOMS OF AGITATION AND NOT BEING THEMSELVES AFTER DRIVING HOME. (THE PATIENT LIVED ¿HOURS¿ AWAY FROM THE CLINIC). THE PATIENT WENT INTO THE ER/HOSPITAL PER CALLER BOTH TIMES AND HAD TO BE SEDATED. IT WAS NOTED THAT THE PATIENT WAS NOT QUITE THEMSELVES FOR APPROXIMATELY 72 HOURS POST REFILL. IT WAS NOTED THAT THE HEALTHCARE PROVIDER (HCP) HAD NOT HEARD FROM THE PATIENT OR FAMILY YET TO SEE IF THERE WERE ANY ADVERSE EFFECTS FOLLOWING THE REFILL YESTERDAY ((B)(6) 2014). IT WAS NOTED THAT THE PATIENT¿S FAMILY MEMBERS WERE NOT GOOD HISTORIANS AND THE PATIENT HAD SOME BEHAVIORAL ¿STUFF¿ GOING ON BUT THE HCP BELIEVED ¿THIS IS A SIGNIFICANT ISSUE FOR THE PATIENT.¿ IT WAS NOTED THAT THE PATIENT¿S RESERVOIR WAS VERY EASY TO ACCESS AND THE HCP BELIEVED ALL THE DRUG WAS PLACED INTO THE RESERVOIR WITH THE REFILL TECHNIQUES SHE UTILIZED. IT WAS NOTED THAT THERE HAD NOT BEEN RESERVOIR VOLUME DISCREPANCIES IN THE PAST (EXTREMELY ACCURATE) EXCEPT FOR THE LAST 2 REFILLS. PATIENT SEEMED TO DO FINE FOR THE REMINDER OF THE REFILL CYCLE PER HCP. IT WAS NOTED THAT IF THE PATIENT HAD SYMPTOMS FROM THE REFILL DONE YESTERDAY, THE HCP WOULD HAVE THE PATIENT COME BACK AND PLAN NEXT STEPS FROM THERE. THE PUMP SYSTEM WAS DELIVERING BACLOFEN. ADDITIONAL INFORMATION RECEIVED REPORTED ANOTHER PUMP OVERDOSE WITH THE PATIENT. THE PUMP WAS FILLED ON THE AFTERNOON OF (B)(6) 2014 WHICH WAS UNEVENTFUL AND ¿TOTALLY NORMAL.¿ IT WAS REPORTED THAT THE HCP FILLED THE RESERVOIR WITH DRUG, ASPIRATED ALL CONTENTS COMPLETELY AND FILLED THE RESERVOIR AGAIN TO BE CERTAIN SHE WAS IN THE RESERVOIR. IT WAS NOTED THAT THIS WAS ¿4 OUT OF THE 4 REFILLS WITH ISSUES.¿ AT 21:30 THE NIGHT OF REFILL PATIENT HAD BECOME A LITTLE AGITATED. THE FOLLOWING DAY THE PATIENT¿S MOTHER WAS WITH THE PATIENT AND NOTICED THE PATIENT WAS EXPERIENCING ¿BOUTS OF UNRESPONSIVENESS AND UNCOOPERATIVENESS, AGITATION AND SCREAMING.¿ IT WAS REPORTED THAT LAST FRIDAY THE PATIENT DEVELOPED A FEVER. PATIENT WAS NOW ON A VENT AND WAS DIAGNOSED WITH ARDS (ACUTE RESPIRATORY DISTRESS SYNDROME). IT WAS NOTED THAT THEY BELIEVED THE PATIENT ASPIRATED FLUID WHEN SHE WAS SCREAMING/AGITATED SO THAT IS HOW THE PATIENT DEVELOPED ARDS. IT WAS NOTED THAT IF THE PATIENT SURVIVES, THEY WILL ACCESS THE RESERVOIR TO COMPARE THE ERV VS THE ARV. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348319 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00026 YR | Hospitalization| L| R |