FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX F250NRE DIALYZER
MDR report key: 3202157
·
Received June 28, 2013
Report
- Report Number
- 1713747-2013-00237
- Event Type
- Malfunction
- Date Received
- June 28, 2013
- Date of Event
- May 29, 2013
- Report Date
- June 1, 2013
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KDI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NO INFORMATION
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 NONCONFORMANCE'S 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
THE USER FACILITY REPORTED A BLOOD LEAK AFTER 20 MINUTES INTO TREATMENT AT THE HEADER OF THE DIALYZER. THE PT LOST APPROXIMATELY 260 C OF BLOOD BUT NO MEDICAL INTERVENTION WAS REQUIRED AND NO INJURY TO THE PT OCCURRED. THE SAMPLE IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295055 | OPTIFLUX F250NRE DIALYZER | KDI | FRESENIUS MEDICAL CARE NORTH AMERICA | 12CU02014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |