FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 160NR DIALYZER FINISHED ASSEMBLY
MDR report key: 4121192
·
Received July 28, 2014
Report
- Report Number
- 1713747-2014-00374
- Event Type
- Malfunction
- Date Received
- July 28, 2014
- Date of Event
- June 27, 2014
- Report Date
- June 27, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- FJI
- PMA / PMN Number
- K002277
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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 TEST OCCURRED. THE MACHINE ALARMED AND TEST STRIPS TESTED POSITIVE. ESTIMATED BLOOD LOSS WAS 150CC'S. PT'S HAD NO ADVERSE EFFECTS AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 439895 | OPTIFLUX 160NR DIALYZER FINISHED ASSEMBLY | FJI | FRESENIUS MEDICAL CARE NORTH AMERICA | 14DU06006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | FRESENIUS 2008T MACHINE |