FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
MDR report key: 3063297
·
Received March 1, 2013
Report
- Report Number
- 1713747-2013-00049
- Event Type
- Malfunction
- Date Received
- March 1, 2013
- Date of Event
- January 17, 2013
- Report Date
- February 4, 2013
- Manufacturer
- OGDEN MANUFACTURING
- 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 DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.
Description of Event or Problem · 1
A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT, A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED AND TEST STRIPS WERE USED TO CONFIRM THE BLOOD LEAK. ESTIMATED BLOOD LOSS WAS 200CC'S. PATIENT HAD NO ILL EFFECTS. SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89890 | OPTIFLUX 160NRE DIALYZER FINISHED ASSY. | HEMODIALYSIS DIALYZER | FJI | OGDEN MANUFACTURING | 12PU03007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | FRESENIUS 2008K MACHINE |