FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 160NRE DIALYZER FINISHED ASSY
MDR report key: 3861062
·
Received April 14, 2014
Report
- Report Number
- 1713747-2014-00186
- Event Type
- Malfunction
- Date Received
- April 14, 2014
- Date of Event
- March 29, 2014
- Report Date
- March 29, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- FJI
- PMA / PMN Number
- K002761
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
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 IN THE DIALYSATE. TEST STRIPS WERE USED TO CONFIRM AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 300 CC'S. PATIENT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. PT COMPLETED TREATMENT ON A NEW SET UP. SAMPLE HAS NOT BEEN RETURNED TO MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228185 | OPTIFLUX 160NRE DIALYZER FINISHED ASSY | FJI | FRESENIUS MEDICAL CARE NORTH AMERICA | 14AU06012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | FRESENIUS 2008K2 HEMODIALYSIS MACHINE |