FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 160NRE DIALYZER FINISHED ASSY
MDR report key: 3952977
·
Received May 20, 2014
Report
- Report Number
- 1713747-2014-00247
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Date of Event
- March 26, 2014
- Report Date
- April 24, 2014
- Manufacturer
- OGDEN MANUFACTURING
- Product Code
- FJI
- PMA / PMN Number
- K002761
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
A HEMODIALYSIS INPATIENT USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED IN THE DIALYSATE AND BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED WITHIN THE DIALYSATE AND BLOOD TEST STRIPS WERE USED. ESTIMATED BLOOD LOSS WAS 240CC'S. PT HAD NO ADVERSE EFFECTS. SAMPLE IS NOT AVAILABLE; SAMPLE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298943 | OPTIFLUX 160NRE DIALYZER FINISHED ASSY | FJI | OGDEN MANUFACTURING | 14BU06005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |