FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX 200NRE DIALYZER FINISHED ASSY.
MDR report key: 3250308
·
Received July 24, 2013
Report
- Report Number
- 1713747-2013-00276
- Event Type
- Malfunction
- Date Received
- July 24, 2013
- Date of Event
- June 24, 2013
- Report Date
- June 24, 2013
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- FJI
- PMA / PMN Number
- K002761
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
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, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED BY THE USER FACILITY THAT A BLOOD LEAK OCCURRED DURING TREATMENT. THE PATIENT'S ESTIMATED BLOOD LOSS WAS LESS THAN 100 CC. THE PATIENT EXPERIENCED NO ADVERSE EFFECTS AS A RESULT AND REQUIRED NO INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346298 | OPTIFLUX 200NRE DIALYZER FINISHED ASSY. | FJI | FRESENIUS MEDICAL CARE NORTH AMERICA | 13EU04003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |