SYNCHROMED II
Report
- Report Number
- 3004209178-2012-09225
- Event Type
- Injury
- Date Received
- October 16, 2012
- Date of Event
- September 22, 2012
- Report Date
- September 22, 2012
- 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
- UK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4). ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND. THE PUMP PASSED PATENCY, DISPENSE AND INFUSION TESTING. THE SEPTUM WAS ALSO MONITORED AND NO LEAKING WAS FOUND. AN 8840 PROGRAMMER WAS USED WITH THE MOST RECENT SOFTWARE CARD THERE WERE NO ISSUES WITH PROGRAMMING. ANALYSIS OF THE 8781 CATHETER REVEALED THAT THE COLLET OF THE PIN CONNECTOR WAS PREMATURELY LOCKED IN PLACE AND WAS NOT FULLY LOCKED IN PLACE. THE CATHETER WAS PATENT ONCE DRIED MATERIAL WAS CLEARED FROM THE LUMEN. THE CATHETER WAS SUBJECT TO A PRESSURE TEST OF UP TO 46 PSI AND NO LEAKING WAS SEEN. THE CATHETER APPEARED TO HAVE NOT BEEN ASSEMBLED CORRECTLY. ONE END OF THE CONNECTOR PIN OF THE CATHETER WAS FULLY INSERTED OVER THE BARB BUT THE COLLET WAS NOT FULLY LOCKED INTO PLACE. ON THE OTHER SIDE OF THIS CONNECTOR THE CATHETER SEGMENT WAS NOT FULLY INSERTED ON THE PIN CONNECTOR AND THE COLLET APPEARED TO HAVE BEEN PREMATURELY LOCKED INTO PLACE.
(B)(4).
PRODUCT ID, 8840 LOT# SERIAL# UNKNOWN, IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID, 8781 LOT# 0206152054 SERIAL#, IMPLANTED: 2012 (B)(6), EXPLANTED: PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT 3 DAYS FOLLOWING A FULL DEVICE SYSTEM REPLACEMENT THE PATIENT EXPERIENCED "EXTREME" MORPHINE OVERDOSE INCLUDING RESPIRATORY ARREST. THE PHYSICIAN ATTEMPTED TO ADJUST THE PATIENT'S DOSE OR STOP THE PUMP USING THE PUMP PROGRAMMER BUT WAS UNSUCCESSFUL AND RECEIVED ERROR MESSAGES OF "PUMP AND CATHETER DATA INVALID", "PUMP MEMORY ERROR" AND "CATHETER INFORMATION INVALID". THE PHYSICIAN DID NOT WANT TO USE THE EMERGENCY STOP BUTTON AND THEREFORE DECIDED THAT THE PUMP WAS TO BE EXPLANTED. THE PATIENT WAS GIVEN AN INFUSION OF NALOXONE AND AT THE TIME OF THE REPORT THE PUMP WAS BEING EXPLANTED. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH INJURY. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE AND CLONIDINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE REPORTER TESTED THE PROGRAMMERS AND SOFTWARE CARDS USING THE DEMO MODE ON THE PROGRAMMER. THE REPORTER SAW THE SAME ERROR MESSAGES AND DETERMINED THAT THE SOFTWARE CARDS WERE OUTDATED AND DID NOT CONTAIN THE INFORMATION OF THE CATHETER THAT WAS IMPLANTED IN THE PATIENT. IN DEMO MODE, THE REPORTER REPROGRAMMED SELECTING ANOTHER CATHETER THAT WAS ON THE NEWER VERSION OF THE APPLICATION CARD AND THE ERROR WAS RESOLVED. THE PUMP SHOWED THAT IT WAS FUNCTIONING AS NORMAL. THE REPORTER STATED THAT THE PUMP AT THE HOSPITAL SHOWED THE SAME BEHAVIOR AND THEREFORE, DID NOT EXPECT THAT SOMETHING WAS WRONG WITH THE PUMP. THE REPORTER STATED THAT THE REASON THE CONSULTANT TRIED TO COMMUNICATE WITH THE PUMP WAS BECAUSE THE PATIENT WENT INTO EXTREME MORPHINE OVERDOSE "WHICH LOOKS LIKE THIS IS A SEPARATE ISSUE NOW".
ADDITIONAL INFORMATION REPORTED THAT THE SOFTWARE CARD WAS CHANGED OUT AND UPDATED ON ONE OF THE TWO PROGRAMMERS. IT WAS STILL UNKNOWN WHETHER THE OTHER PROGRAMMER¿S SOFTWARE CARD WAS UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR | Life Threatening| R |