FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 160NR DIALYZER FINISHED ASSEMBLY
MDR report key: 2860596
·
Received December 5, 2012
Report
- Report Number
- 1713747-2012-00228
- Event Type
- Malfunction
- Date Received
- December 5, 2012
- Date of Event
- November 7, 2012
- Report Date
- November 8, 2012
- Manufacturer
- OGDEN MANUFACTURING
- Product Code
- FJI
- PMA / PMN Number
- K003498
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CAN NOT 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, 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 BY THE NURSE AT THE CONNECTION BETWEEN THE HANSEN CONNECTOR. BLOOD STRIPS CONFIRMED THE BLOOD LEAK. ESTIMATED BLOOD LOSS WAS 220CC'S THERE IS NO OTHER KNOWN ILL EFFECT TO THE PATIENT. SAMPLE IS AVAILABLE FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTIFLUX 160NR DIALYZER FINISHED ASSEMBLY | HEMODIALYSIS DIALYZERS | FJI | OGDEN MANUFACTURING | 11EU03012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | FRESENIUS 2008K MACHINE |