FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2171017
·
Received June 30, 2011
Report
- Report Number
- 3004209178-2011-04965
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 7, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2011, IT WAS REPORTED THAT AN ERROR WAS MADE IN PROGRAMMING THE PUMP AT THE LAST REFILL. THE MORPHINE CONCENTRATION SHOULD HAVE READ 40MG/ML WITH BUPIVACAINE 15MG/ML, BUT IT READ 20MG/ML WITH BUPIVACAINE 15MG/ML. NO SIGNS OR SYMPTOMS WERE REPORTED. INTERVENTION WAS REPORTED AS REPROGRAMMING/REFILL/BOLUS WITH CONCENTRATION AND RATE ADJUSTMENT ON (B)(6) 2011. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE REPORTED IF IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | IMPLANTED:| CATHETER: MODEL 8709, LOT# N099144012| EXPLANTED: |