FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
MDR report key: 2894622
·
Received December 27, 2012
Report
- Report Number
- 1713747-2012-00254
- Event Type
- Malfunction
- Date Received
- December 27, 2012
- Date of Event
- November 30, 2012
- Report Date
- November 30, 2012
- Manufacturer
- OGDEN MANUFACTURING
- Product Code
- FJI
- PMA / PMN Number
- K002761
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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 RIGHT AT THE BEGINNING OF TREATMENT AND THE MACHINE ALARMED. RN STATED THAT THE BLOOD COULD BE SEEN MIXING WITH THE DIALYSATE. ESTIMATED BLOOD LOSS WAS 100CC'S. PT HAD NO ILL EFFECTS. SAMPLE WAS DISCARDED BY THE USER FACILITY; SAMPLE IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTIFLUX 180NRE DIALYZER FINISHED ASSY. | HEMODIALYSIS DIALYZER | FJI | OGDEN MANUFACTURING | 12NU02007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | FRESENIUS 2008K MACHINE |