SYNCHROMED II
Report
- Report Number
- 3004209178-2013-10667
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- March 28, 2013
- Report Date
- November 30, 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
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, ¿SYNCHROMED II IMPLANTABLE DRUG INFUSION PUMP ¿ OVERINFUSION" (B)(6) 2014.
ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
PRODUCT ID: 8590-1 LOT# N154147, IMPLANTED: 2008 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID: 8709SC SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE CATHETER. (B)(4).
ADDITIONAL ANALYSIS WAS PERFORMED. THE ALARM WAS RETESTED AND PASSED THE ALARM TEST. DESTRUCTIVE ANALYSIS WAS COMPLETED AND NO ADDITIONAL ANOMALIES WERE FOUND DURING THE DESTRUCTIVE ANALYSIS. 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 MEDICAL PRODUCTS: PRODUCT ID 8590-1, LOT# N154147, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. LONG TERM TESTING FOR THE PUMP HAS BEEN COMPLETED AND ANALYSIS CONFIRMED THAT THE PUMP WAS OVERINFUSING WITH AN UNDETERMINED ROOT CAUSE. THE ALARM WAS RETESTED AND PASSED. NO SIGNIFICANT ANOMALIES WERE FOUND DURING DESTRUCTIVE ANALYSIS. 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.
ANALYSIS OF THE PUMP REVEALED OVER INFUSION. THE ROOT CAUSE WAS UNDETERMINED. DISCOLORED FLUID WAS REMOVED FROM THE PUMP RESERVOIR. THERE WAS A DENT IN THE TOP SHIELD. ALARM TESTING FAILED DB LEVEL TEST BUT THE ALARM DID SOUND. DISPENSE ACCURACY TESTING FAILED AND DISPLAYED OVER INFUSION. A 15 HOUR 300 UL/DAY INFUSION TEST WAS PERFORMED AND PASSED FOR ACCURACY. THE OVER INFUSION WAS INTERMITTENT DURING LAB TESTING.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS INITIALLY REPORTED THAT WHILE THE HEALTHCARE PROVIDER (HCP) WAS ASPIRATING OLD MEDICATION FROM THE PUMP, THE EXPECTED RESIDUAL VOLUME WAS 6.3ML AND THE ACTUAL RESIDUAL VOLUME WAS 7ML. AFTER THE MEDICATION WAS ASPIRATED, THE HCP WAS MAINTAINING NEGATIVE PRESSURE ON THE PLUNGER AND BRIGHT RED BLOOD STARTED TO ASPIRATE INTO THE TUBING. THE HCP THEN CLAMPED THE TUBING AND RECONFIRMED DURING THE PROCESS THAT THE NEEDLE WAS STILL RESTING ON THE NEEDLE STOP WITHIN THE PUMP. THE PHYSICIAN THEN ATTEMPTED THE SAME, AND CONTINUED TO ASPIRATE BLOOD INTO THE TUBING. THE PUMP WAS REFILLED WITH PRESERVATIVE FREE NORMAL SALINE, AND THE PATIENT WAS STARTED ON FENTANYL PATCHES. IT WAS NOTED THAT THE NEEDLE AND TUBING WERE NOT SAVED FOR RETURN AND ANALYSIS. THE PATIENT EXPERIENCED NO SYMPTOMS/INJURIES RELATED TO THIS EVENT. THE PATIENT WAS BEING REFERRED TO ANOTHER HCP FOR POSSIBLE SYSTEM CHANGE. THE PUMP WAS DELIVERING FENTANYL. IT WAS LATER REPORTED THAT THE PATIENT WAS SCHEDULED FOR A REVISION ON (B)(6) 2013. THE PATIENT INITIALLY PLANNED ON HAVING THE SYSTEM EXPLANTED, BUT SINCE HAVING ONLY SALINE IN THE PUMP, THE PATIENT CHANGED HER MIND AND DECIDED TO KEEP THE PUMP AND CONTINUE THERAPY, THUS THE PUMP WAS CHANGED OUT ON (B)(6) 2013. IT WAS NOTED THAT DURING THE PUMP REVISION, THE CATHETER WAS ABLE TO BE ASPIRATED FREELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL REVIEW INDICATED THE INFORMATION PREVIOUSLY REPORTED IN MANUFACTURER REPORT # 3004209178-2013-07027 PERTAINS TO THE EVENTS IN THIS MANUFACTURER REPORT. ALL FURTHER INFORMATION RECEIVED WILL BE REPORTED UNDER THIS MANUFACTURER NUMBER.
ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO VOLUME DISCREPANCY. THE DATE OF ONSET OF THE EVENT WAS (B)(6) 2013. THE PUMP REFILL WAS DONE ON THAT DATE IN WHICH BLOOD WAS ASPIRATED BACK IN THE TUBING AFTER THE EXPECTED VOLUME WAS REMOVED FROM THE PUMP. THE REFILL WAS STOPPED AND THEN THE PHYSICIAN NOTIFIED AND CALLED TO BEDSIDE. THE DECISION WAS MADE TO NOT FILL THE PUMP WITH FENTANYL AND REFILL WITH NORMAL SALINE. THE PUMP WAS CHANGED OUT ON (B)(6) 2013 AND FENTANYL WAS ADDED BACK TO THE PUMP ON (B)(6) 2013. THERE WAS NO ISSUE WITH THE NEW PUMP. REFILL DATA WAS REPORTED FOR THE PAST 13 REFILLS DATING BACK TO (B)(6) 2010. THE PUMP HAD BEEN FILLED WITH FENTANYL EXCEPT FOR A REFILL ON (B)(6) 2011, WHEN THE PUMP WAS FILLED WITH NORMAL SALINE FOR 10 DAYS UNTIL IT WAS REFILLED WITH FENTANYL, AND THE PREVIOUSLY REPORTED (B)(6) 2013 REFILL. A BRIDGE BOLUS WAS PERFORMED. THE PUMP WAS ROUTINELY FILLED WITH 19 MILLILITERS (ML) ON EACH REFILL WITH THE EXCEPTION OF (B)(6) 2011, WHEN THE PUMP WAS FILLED WITH 19.2 ML. THERE WERE VOLUME DISCREPANCIES REPORTED WITH THE FOLLOWING REFILLS: (B)(6) 2010, THE EXPECTED RESIDUAL VOLUME WAS 1.6 ML, AND THE ACTUAL RESIDUAL VOLUME WAS 2 ML; (B)(6) 2011, THE EXPECTED RESIDUAL VOLUME WAS 4.8 ML, AND THE ACTUAL RESIDUAL VOLUME WAS 5.0 ML; (B)(6) 2011, THE EXPECTED RESIDUAL VOLUME WAS 16.3 ML, AND THE ACTUAL RESIDUAL VOLUME WAS 16.0 ML; (B)(6) 2012, THE EXPECTED RESIDUAL VOLUME WAS 2.8 ML, AND THE ACTUAL RESIDUAL VOLUME WAS 3.2 ML; (B)(6) 2012, THE EXPECTED RESIDUAL VOLUME WAS 4.0 ML, AND THE ACTUAL RESIDUAL VOLUME WAS 3.0 ML; (B)(6) 2013, THE EXPECTED RESIDUAL VOLUME WAS 4.8 ML, AND THE ACTUAL RESIDUAL VOLUME WAS 5.2 ML; (B)(6) 2013, THE EXPECTED RESIDUAL VOLUME WAS 3.4 ML, AND THE ACTUAL RESIDUAL VOLUME WAS 4.0 ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281760 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00044 YR | Hospitalization| R |