FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3821981
·
Received May 20, 2014
Report
- Report Number
- 3004209178-2014-09313
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Report Date
- April 25, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PUMP REFILL ONE OF THE LIORESAL AMPULES SHATTERED WHILE TRYING TO POP OFF THE TOP OF THE AMPULE. PATIENT WAS SENT HOME WITHOUT REFILLING THE PUMP. THE PUMP SYSTEM WAS DELIVERING LIORESAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD 15 DAYS LEFT FROM THE DAY OF REPORT CONSIDERING A RESERVOIR VOLUME OF 4.4ML. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DOSE WAS NOT DETERMINED. PATIENT WAS RESCHEDULED FOR A REFILL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULED FOR FRIDAY THE ((B)(6) 2014) AND THE NEW MEDICATION WAS SHIPPED IN FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300216 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00040 YR |