SYNCHROMED II
Report
- Report Number
- 3004209178-2013-01077
- Event Type
- Injury
- Date Received
- January 29, 2013
- Date of Event
- October 10, 2012
- Report Date
- January 10, 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 Occupation
- NURSE
Narratives
PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).
PUMP PASSED DISPENSE AND INFUSION ACCURACY TESTING. NO REAL SIGNIFICANT ISSUES FOUND WITH PUMP PERFORMANCE. A VISUAL NOTE WAS MADE BY THE LAB THAT THERE ARE EXCESSIVE NEEDLE MARKS NEAR THE CAP (CATHETER ACCESS PORT) SEPTUM. CATHETER WAS RETURNED IN TWO SEGMENTS. THE DISTAL END OF THE SPINAL SEGMENT WHICH INCLUDES THE DISPENSING HOLES WAS NOT RETURNED. MINOR BLEMISHES NOTED WHICH INCLUDE SOME INDENTS ON THE RETAINING RING FINGERS AND AN INDENT DOWN INSIDE OF THE CUP OF THE SC. ALSO NOTED WAS A SLIGHT ABRASION OVER THE 30 CM MARKER ON THE SPINAL SEGMENT. THESE BLEMISHES DID NOT AFFECT CATHETER PERFORMANCE.
PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4).
(B)(4).
(B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER A PUMP REFILL WITH OVERDOSE SYMPTOMS; THEIR CONDITION DETERIORATED, REQUIRING INTUBATION. THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), GOT BETTER, AND WAS SENT TO RECOVERY. THE PATIENT STOPPED BREATHING AND WAS SENT BACK TO ICU AND PUT BACK ON THE VENTILATOR. THE DECISION WAS MADE TO REMOVE THE PUMP AS A PRECAUTIONARY MEASURE DUE TO A POSSIBLE MALFUNCTION OF THE PUMP. (SEE ATTACHED USER FACILITY MEDWATCH). IT WAS NOTED THAT NO DIAGNOSTICS WERE PERFORMED. THE PUMP AND CATHETER WERE EXPLANTED ON (B)(6) 2013. THE REASON GIVEN FOR EXPLANT WAS "PATIENT MEDICAL ISSUES". THE PATIENT RECOVERED AND WAS RELEASED. ON (B)(6) 2013, THE PATIENT WAS EVALUATED AT THE CLINIC AND WAS REPORTED TO BE DOING WELL. THE HEALTH CARE PROVIDER (HCP) COULD NOT SAY THAT THE PUMP WAS WHAT CAUSED THE EVENT, BUT THE DECISION WAS MADE TO NOT CONTINUE THERAPY WITH THE PUMP AND A NEW PUMP WAS NOT GOING TO BE PLACED AT THAT POINT. ON (B)(6) 2013, THE PUMP WAS RELEASED BY THE HOSPITAL AND WAS TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS, SINCE THE PATIENT PRESENTED TO THE ER (EMERGENCY ROOM) JUST AFTER A PUMP REFILL. THE PUMP WAS PROGRAMMED TO MINIMUM FLOW RATE WHEN IT WAS OBTAINED BY THE HOSPITAL'S RISK MANAGEMENT. THE PUMP SYSTEM WAS BEING USED TO DELIVER COMPOUNDED BACLOFEN AND "OTHER". IT WAS NOTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED RESPIRATORY FAILURE AND AN ALTERED MENTAL STATUS FOLLOWING PUMP REFILLS. ON (B)(6) 2012, A REFILL WAS DONE AND WITHIN 24 HOURS THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) WITH RESPIRATORY FAILURE AND AN ALTERED MENTAL STATUS. THE PATIENT WAS VENTILATED. THE PATIENT WAS WEANED OFF ALL INTRATHECAL, INTRAVENOUS AND ORAL MEDICATIONS, CAME OFF OF THE VENTILATOR AND WAS DISCHARGED. THE DISCHARGE DIAGNOSIS WAS PROBABLE BACLOFEN REACTION/ALLERGY. NO DIAGNOSTICS WERE DONE DURING THIS HOSPITALIZATION. AT A REFILL ON (B)(6) 2013, THE EXPECTED RESIDUAL VOLUME WAS 13.9ML AND THE ACTUAL VOLUME WAS 0.5ML. IT WAS BELIEVED THAT BUPIVACAINE CONTRIBUTED TO THE PREVIOUS EVENT, SO THE PUMP WAS NOT REFILLED WITH IT. A 40% DECREASE WAS DONE. THE FOLLOWING DAY, THE PATIENT WENT TO THE EMERGENCY ROOM WITH AN ALTERED MENTAL STATUS AND BREATHING ISSUES. THE PATIENT WAS ADMITTED TO THE MEDICAL RESPIRATORY ICU FOR AND WAS VENTILATED. HE WAS BEING KEPT SEDATED. THE FOLLOWING DAY, THE PUMP WAS INTERROGATED AND WAS ALREADY MISSING 2ML OF FLUID. THE PUMP WAS PROGRAMMED AT A SLOW RATE, SO THIS WAS NOT POSSIBLE. A LEAK WAS REPORTED. DIAGNOSTICS, INCLUDING A DYE STUDY, WAS DISCUSSED, HOWEVER HAD NOT BEEN DONE YET. AT REFILLS ON (B)(6) 2012 AND (B)(6) 2013, THEY WERE SURE THE PUMP WAS ACCESSED CORRECTLY AS IT WAS SUPERFICIAL, EASILY ACCESSED, DID NOT MOVE, AND TWO SETS OF HANDS WERE USED TO ENSURE THE NEEDLE STAYED AT THE BACK OF THE NEEDLE STOP THE ENTIRE REFILL. THE 15% INCREASES WERE DONE ON (B)(6) 2012 AND (B)(6) 2013. THE PATIENT CAME IN FOR ADJUSTMENTS MONTHLY LEADING UP TO THE RECENT EVENT WHERE HE EXPERIENCED THE SAME SYMPTOMS. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID (HYDROMORPHONE), LIORESAL (BACLOFEN) AND CLONIDINE.
ADDITIONAL INFORMATION WAS RECEIVED FROM A HCP (HEALTHCARE PROVIDER) STATED THAT THE NEEDLE MARKS NOTED DURING MANUFACTURER ANALYSIS, THE MARKS WERE FROM AN ATTEMPT TO PERFORM A DYE STUDY. THE PHYSICIAN WAS STILL NOT SURE WHY THE OVERDOSE OCCURRED.
ADDITIONAL REVIEW REPORTED THAT CONCENTRATION OF CLONIDINE WAS INCREASED FROM 200 UG/ML TO 400 UG/ML DURING THE REFILL ON (B)(6) 2013 BUT A BRIDGE BOLUS WAS NOT PERFORMED. TELEMETRY STRIP OF THE PUMP ALSO SHOWED A MOTOR STALL AND A MOTOR STALL RECOVERY OCCURRED ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38594 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00042 YR | Hospitalization| L| R |