FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
MDR report key: 4022976
·
Received July 11, 2014
Report
- Report Number
- 1713747-2014-00342
- Event Type
- Malfunction
- Date Received
- July 11, 2014
- Date of Event
- June 11, 2014
- Report Date
- June 11, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA, OGDEN MANUFACTURING
- Product Code
- FJI
- PMA / PMN Number
- K002761
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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. BLOOD TEST STRIPS WERE USED, THE LEAK WAS VISUALLY OBSERVED AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 200CC'S. PATIENT HAD NO ADVERSE EFFECTS AND REQUIRED NO MEDICAL INTERVENTION. SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 408166 | OPTIFLUX 160NRE DIALYZER FINISHED ASSY. | FJI | FRESENIUS MEDICAL CARE NORTH AMERICA, OGDEN MANUFACTURING | 14CU06026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 MO | FRESENIUS 2008K2 MACHINE |