FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
MDR report key: 3060782
·
Received April 5, 2013
Report
- Report Number
- 1713747-2013-00083
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Date of Event
- March 8, 2013
- Report Date
- March 8, 2013
- Manufacturer
- OGDEN MANUFACTURING
- Product Code
- FJI
- PMA / PMN Number
- K002761
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT, A BLOOD LEAK OCCURRED. PT WAS 37 MINS INTO TREATMENT WHEN THE MACHINE ALARMED AND TEST STRIPS CONFIRMED THE INTERNAL BLOOD LEAK. ESTIMATED BLOOD LOSS WAS 100 CC'S. PT HAD NO ILL EFFECTS. SAMPLE IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 141895 | OPTIFLUX 160NRE DIALYZER FINISHED ASSY. | HEMODIALYSIS DIALYZER | FJI | OGDEN MANUFACTURING | 13AU03004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | FRESENIUS T MACHINE |