FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
MDR report key: 3882867
·
Received April 4, 2014
Report
- Report Number
- 1713747-2014-00169
- Event Type
- Malfunction
- Date Received
- April 4, 2014
- Date of Event
- March 10, 2014
- Report Date
- March 14, 2014
- Manufacturer
- OGDEN MANUFACTURING
- Product Code
- FJI
- PMA / PMN Number
- K002761
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, 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 AT THE TOP OF THE DIALYZER, RUNNING DOWN THE LINE AND LEAK ON THE FLOOR. THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS LESS THAN 50CC'S. PT HAD NO ADVERSE EFFECTS AND REQUIRED NO MEDICAL INTERVENTION. SAMPLE IS NOT AVAILABLE; SAMPLE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204940 | OPTIFLUX 180NRE DIALYZER FINISHED ASSY. | FJI | OGDEN MANUFACTURING | 14BU03004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | FREESENIUS 2008K MACHINE |