SYNCHROMED II
Report
- Report Number
- 3004209178-2013-06679
- Event Type
- Injury
- Date Received
- April 22, 2013
- Report Date
- March 25, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-2380-2008&Z-1575-2013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
(B)(4).
PRODUCT ID 8709SC, LOT# 0205600504, PRODUCT TYPE: CATHETER.
(B)(4).
ANALYSIS OF THE PUMP (S/N: (B)(4)) FOUND NO ANOMALY. THERE WAS A CREASE AND WEAR MARKS IN THE PUMP TUBING, BUT IT DID NOT AFFECT THE FUNCTIONALITY OF THE PUMP.
CORRECTED INFORMATION: NO EVAL EXPLAIN CODE .IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE PATIENT WAS SEEN AGAIN AND WAS DOING VERY WELL, BUT AGAIN NOTHING HAD INFUSED FROM THE PUMP. BECAUSE THE PATIENT WAS DOING VERY WELL THE PHYSICIAN SENT HER BACK TO THE NURSING HOME AND PLANNED TO REVIEW THE SITUATION IN 3 MONTHS. IT WAS LATER REPORTED THAT ONE INDIVIDUAL AT THE CLINIC FELT THAT THE ISSUE WAS RELATED TO THE SUTURELESS CATHETER CONNECTOR SINCE THE PATIENT WAS IMPLANTED WITH A SUTURELESS CONNECTOR. THE PHYSICIAN WAS RELUCTANT TO DO ANYTHING BECAUSE THE PATIENT WAS SAYING THAT SHE WAS FINE EVEN THOUGH NOW FOR THE SECOND TIME THE EXPECTED PUMP VOLUME WAS 3ML AND THE ACTUAL VOLUME FOUND WAS 40 ML. THE PHYSICIAN FELT THE ISSUE WAS WITH THE PUMP.
IT WAS LATER REPORTED THAT THE PUMP WAS ONLY DELIVERING BACLOFEN.
IT WAS LATER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED. THE EXPECTED RESIDUAL VOLUME (ERV) WAS 22.7 ML AND THE ACTUAL RESIDUAL VOLUME (ARV) WAS 40 ML. IT WAS AGAIN NOTED THAT EVER SINCE THE PUMP WAS IMPLANTED THERE HAVE BEEN VOLUME DISCREPANCIES. AT EVERY REFILL WHEN THE HCP INTERROGATED, THE PUMP AND ASCERTAINED WHAT THE VOLUME OF FLUID EXPECTED IN THE RESERVOIR; HOWEVER, UPON EMPTYING THE RESERVOIR IT WAS FOUND TO BE STILL FULL WITH 40 ML OF DRUG (AS PREVIOUSLY REPORTED). THEN OVER THE PAST FEW MONTHS THE PATIENT HAD BEEN EXPERIENCING MORE PAIN AND SPASTICITY; THEREFORE, THE DECISION WAS MADE TO INTERVENE. DURING THE REVISION, THE HCP DISCONNECTED THE CATHETER FROM THE PUMP AND CHECKED THAT THE CATHETER WAS PATENT. IT WAS NOTED THERE WAS BACKFLOW OF CEREBROSPINAL FLUID (CSF) AND THEY WERE ABLE TO FLUSH THE CATHETER WITH NO OBSTRUCTION. THEY THEN FLUSHED THE CATHETER ACCESS PORT (CAP) THROUGH AND NO OBSTRUCTIONS WERE OBSERVED. THE PUMP WAS OBSERVED FOR SEVERAL MINUTES TO SEE IF ANY DRUG THEN CAME THROUGH THE PORT AND NOTHING APPEARED. AT THAT POINT THE HCP MADE THE DECISION TO REPLACE THE PUMP WITH A NEW ONE. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ¿ALIVE NO INJURY¿. THE PATIENT HAD SYMPTOMS OF THEY DID NOT APPEAR TO BE RECEIVING ANY SYMPTOM RELIEF FROM THE PUMP. THE PUMP SYSTEM WAS BEING USED TO DELIVER LIORESAL.
IT WAS LATER REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WANTED TO "LEAVE THE PATIENT AS THEY ARE HAPPY THAT THEY HAVE NO 'SYSTEMS' AND THE PATIENT IS HAPPY". IT WAS LATER REPORTED THAT AT THE LAST REFILL, AGAIN ANOTHER 40ML WAS REMOVED FROM THE PUMP. THE PATIENT WAS DOING WELL AND THE HCP DID NOT INTEND TO DO ANYTHING AND WOULD MONITOR THE PATIENT.
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON THE (B)(6) 2012 AND THE PUMP WAS FILLED WITH 40 ML OF 500MCG BACLOFEN AND INITIALLY RUN AT 75MCG PER DAY WITH A REFILL DATE IN (B)(6) 2013. THE PATIENT WAS EVALUATED POST IMPLANT AS AN INPATIENT AND THE PUMP RATE WAS INCREASED TO 100MCG PER DAY AND A REFILL DATE OF (B)(6) 2013 WAS RECORDED. THE PATIENT WAS EVALUATED IN THE OUTPATIENT DEPARTMENT ON THE (B)(6) 2012 AND THE PUMP RATE WAS INCREASED TO 125MCG PER DAY AND A REFILL DATE OF THE (B)(6) 2013 WAS RECORDED. THE REFILL DATE ON THE PUMP REMAINED THE (B)(6) 2013. THE PATIENT WAS EVALUATED ON (B)(6) 2013 AND THE PUMP WAS INTERROGATED. IT WAS NOTED THAT THERE WAS A VOLUME DISCREPANCY WITH THE PUMP. THE EXPECTED RESIDUAL VOLUME WAS 3.5 ML, AND THE ACTUAL ASPIRATED VOLUME WAS 40 ML. THE PUMP WAS EMPTIED, REFILLED, AND PROGRAMMED TO 125 MCG PER DAY. THE PUMP SYSTEM WAS DELIVERING BACLOFEN. IT WAS LATER REPORTED THAT THE PATIENT DISPLAYED NO SIGNS OR SYMPTOMS RELATED TO THIS EVENT. AFTER THE PUMP WAS IMPLANTED, THE PATIENT MOVED INTO A NURSING HOME WITH 24 HOUR CARE. THIS CORRESPONDED WITH AN IMPROVEMENT IN THE PATIENT'S CONDITION, WHICH WAS ATTRIBUTED TO THE MOVE AND THE IMPLANTATION OF THE PUMP. THE PATIENT WILL BE REVIEWED AGAIN IN TWO WEEKS WHEN THE PUMP WILL BE EMPTIED TO EXAMINE IF THE DESIRED AMOUNT HAD BEEN ADMINISTRATED, OR IF THE PUMP WAS STILL NOT DELIVERING ANY MEDICATION. IT WAS NOTED THE PATIENT'S STATUS HAD NOT CHANGED IN ANY WAY AND THE PATIENT WAS NOTED TO BE COMFORTABLE. NO TROUBLESHOOTING HAD BEEN PERFORMED AND IT WAS NOTED WHEN THE PUMP HAD BEEN INTERROGATED IN THE OUTPATIENT DEPARTMENT BEFORE IT WAS DUE TO BE REFILLED, THERE WERE NO LOG MESSAGES AND THE PUMP READ AS IT SHOULD HAVE. 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 |
|---|---|---|---|---|---|---|---|
| 171292 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00045 YR | Required Intervention |