FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 160NRE DIALYZER FINISHED ASSY
MDR report key: 2945381
·
Received February 1, 2013
Report
- Report Number
- 1713747-2013-00024
- Event Type
- Malfunction
- Date Received
- February 1, 2013
- Date of Event
- January 2, 2013
- Report Date
- January 7, 2013
- Manufacturer
- OGDEN MFG
- Product Code
- FJI
- PMA / PMN Number
- K002761
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 240CC'S. A NEW SYS WAS STRUNG AND THE PT CONTINUED TREATMENT. PT HAD NO ILL EFFECTS. SAMPLE IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 44498 | OPTIFLUX 160NRE DIALYZER FINISHED ASSY | HEMODIALYSIS DIALYZER | FJI | OGDEN MFG | 12LU01017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |