FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3120894
·
Received May 20, 2013
Report
- Report Number
- 3004209178-2013-07944
- Event Type
- Malfunction
- Date Received
- May 20, 2013
- Report Date
- April 23, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
A HEALTHCARE PROVIDER REPORTED THAT, THEY ¿HAD ANOTHER LADY THAT IS¿IT¿S¿HERS WAS FLIPPED¿. IT WAS FURTHER STATED THAT ¿THEY HAD NEVER HAD ONE FLIP COMPLETELY OVER¿. THE HEALTHCARE PROVIDER INDICATED THEY WERE ABLE TO ACCESS THE PUMP WITH THE HELP OF A SECOND NURSE. THE MEDICATION USED WITHIN THE SYSTEM WAS FENTANYL. NO SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222218 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |