FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 180NRE DIALYZER FINISHED ASSY
MDR report key: 3982905
·
Received June 25, 2014
Report
- Report Number
- 1713747-2014-00328
- Event Type
- Malfunction
- Date Received
- June 25, 2014
- Date of Event
- June 3, 2014
- Report Date
- June 6, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- FJI
- PMA / PMN Number
- K002761
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED FROM THE ARTERIAL HEADER OF THE DIALYZER. ESTIMATED BLOOD LOSS WAS 10CC'S. PATIENT 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 |
|---|---|---|---|---|---|---|---|
| 370633 | OPTIFLUX 180NRE DIALYZER FINISHED ASSY | FJI | FRESENIUS MEDICAL CARE NORTH AMERICA | 14DU05006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | FRESENIUS 2008T MACHINE |