FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2180715
·
Received July 7, 2011
Report
- Report Number
- 3004209178-2011-05161
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- May 20, 2011
- Report Date
- June 14, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PUMP REPLACEMENT THE PUMP LOCKED. THE PHYSICIAN EXTRACTED STERILE WATER FROM THE PUMP, AND FILLED WITH 13ML OF THE DRUG, FOLLOWING WHICH THE PUMP LOCKED. THE DRUG COULD NOT BE EXTRACTED AND THE LOCK COULD NOT BE RELEASED. THE PUMP WAS NOT USED, A NEW ONE WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |