FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
MDR report key: 3922218
·
Received May 23, 2014
Report
- Report Number
- 1713747-2014-00253
- Event Type
- Malfunction
- Date Received
- May 23, 2014
- Date of Event
- April 30, 2014
- Report Date
- April 30, 2014
- Manufacturer
- OGDEN MANUFACTURING
- Product Code
- FJI
- PMA / PMN Number
- K002761
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A F/U 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 OUTSIDE THE DIALYZER AND THE MACHINE ALARMED. DIALYZER HAS A CRACK ON THE ARTERIAL SIDE OF TOP PART BY THE HEAD. ESTIMATED BLOOD LOSS WAS 250 CC'S. PT DID NOT REQUIRE ANY MEDICAL INTERVENTION. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307141 | OPTIFLUX 180NRE DIALYZER FINISHED ASSY. | FJI | OGDEN MANUFACTURING | 14CU05004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | FRESENIUS 2008K MACHINE |