SYNCHROMED II
Report
- Report Number
- 3004209178-2014-12965
- Event Type
- Injury
- Date Received
- July 14, 2014
- Date of Event
- June 19, 2014
- Report Date
- November 19, 2014
- 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
- SW
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4).
ANALYSIS OF THE PUMP REVEALED DURING INITIAL DESTRUCTIVE ANALYSIS, PUMP COMPONENTS APPEARED CLEAN WITH LITTLE EVIDENCE OF CORROSION ON THE M2 FEEDTHRU. FINAL DESTRUCTIVE ANALYSIS WAS PERFORMED AND PUMP COMPONENTS WERE THOROUGHLY INSPECTED WITH LITTLE EVIDENCE OF RESIDUE IN THE PINION. IN CONCLUSION, ANALYSIS CONFIRMED THE PUMP MOTOR STALL BUT THE ROOT CAUSE OF THE MOTOR STALL COULD NOT BE DETERMINED.
A FURTHER INQUIRY WAS MADE TO DETERMINE THE PUMP STATUS AND IT WAS PROVIDED THAT THE PUMP REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ALTERED MENTAL STATUS, FEVER, HEADACHE, PAIN, INCREASED SPASTICITY, AND UNDERDOSE SYMPTOMS. A PUMP FAILURE OCCURRED AS A MOTOR STALL WAS ALSO REPORTED THAT HAD NOT RECOVERED. THIS REQUIRED HOSPITALIZATION FOR THE PATIENT. IT WAS UNCLEAR AS TO IF A POSSIBLE POCKET FILL OCCURRED. THE PUMP REMAINS IMPLANTED BUT OUT-OF-SERVICE. DIAGNOSTIC TESTING/TROUBLESHOOTING INCLUDED CHECKING THE LOGS. THE ISSUE WAS NOT RESOLVED AND THE CAUSE WAS NOT DETERMINED. AT THE TIME OF THE REPORT, THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY. THIS DEVICE SYSTEM DELIVERED MORPHINE. THE PUMP WAS EXAMINED ON (B)(6) 2014 AT 11:15 AND THE LOGS INDICATED THAT ON (B)(6) 2014 AT 12:39 A MOTOR STALL OCCURRED. THE ALARM WAS ALSO SILENCED ON (B)(6) AT 23:31 AND MINIMUM RATE WAS NOTED. ADDITIONAL INFORMATION FOR EVENT CLARIFICATION HAD BEEN REQUESTED. IT WAS FURTHER PROVIDED THAT THE PATIENT WAS NOT EXPOSED TO ANY MAGNETIC FIELDS AND DID NOT HAVE A MOBILE PHONE CLOSE TO THE PUMP. FOR CLARIFICATION, THE PUMP ALARM STARTED EARLY IN THE AFTERNOON THE (B)(6), CONSISTENT WITH THE LOG 00.30 PM (SHOWN AS 12.30 PM IN THE LOG). IN THE EVENING, THE PATIENT WENT TO THE EMERGENCY WARD AND THE MANUFACTURER REPRESENTATIVE WAS INFORMED APPROXIMATELY 10 PM THAT SAME DAY AND BY PHONE INSTRUCTED THE NEUROSURGEON HOW TO SILENCE THE ALARM AND ALSO INSTRUCTED HOW TO PROGRAM THE PUMP ON MINIMAL RATE TO AVOID OVER-MEDICATION AS ORAL MEDICATION WAS INITIATED TO TREAT ABSTINENCE SYMPTOMS. THE READING ON THE (B)(6) WAS JUST THE MANUFACTURER REPRESENTATIVE READING THE PUMP TO CHECK THE CORRECTNESS OF THE PROGRAMMING. AFTER 48 HOURS, THE PUMP (AS EXPECTED) ONCE AGAIN STARTED ALARMING WITH THE INFORMATION THAT 48 HOURS HAD ELAPSED AND THAT THE PUMP THEREFORE, HAD TO BE CHANGED (¿NOT THE EXACT WORDING BUT SOMETHING LIKE IT.¿) THE ALARM WAS ONCE AGAIN SILENCED AND THE PUMP WAS STOPPED AS THE PATIENT WENT HOME WITH ORAL MEDICATION. THE ONLY DRUG THAT HAS BEEN USED WAS MORPHINE-HYDROCHLORIDE FOR INTRATHECAL USE AND WITHOUT ANY PRESERVATIVES. THEREFORE, THE PH WAS SUPPOSED TO BE WITHIN EXPECTED VALUES. NO SEPARATE TESTS HAVE BEEN PERFORMED ON THE SOLUTION. THE ALARM WAS SILENCED AS THE PATIENT NEEDED TO BE ABLE TO SLEEP. THE PATIENT WAS ALSO REFERRED FOR NEW PUMP-IMPLANTATION. THE PUMP WAS EXPECTED TO BE RETURNED FOR ANALYSIS UPON ITS EXPLANT. IT WAS LATER CONFIRMED THAT THERE WAS NO POCKET FILL ALLEGED OR ASSOCIATED WITH THIS EVENT.
FURTHER, A NEW PUMP WAS SUCCESSFULLY IMPLANTED AND THE PATIENT WAS CURRENTLY RECEIVING EFFECTIVE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409425 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00073 YR | Hospitalization| R |