FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
MDR report key: 3190475
·
Received June 21, 2013
Report
- Report Number
- 1713747-2013-00229
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 30, 2013
- Report Date
- May 30, 2013
- Manufacturer
- OGDEN MANUFACTURING
- Product Code
- FJI
- PMA / PMN Number
- K002761
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL WERE WITHIN SPECIFICATION.
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 AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 150CC'S. PATENT HAD NO ADVERSE EFFECTS. SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283815 | OPTIFLUX 180NRE DIALYZER FINISHED ASSY. | FJI | OGDEN MANUFACTURING | 13CU02005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HEMODIALYSIS MACHINE |