FDA Adverse Event
Malfunction
Summary report: N
OPTIFLUX F250NRE DIALYZER
MDR report key: 3922201
·
Received May 23, 2014
Report
- Report Number
- 1713747-2014-00255
- Event Type
- Malfunction
- Date Received
- May 23, 2014
- Date of Event
- March 31, 2014
- Report Date
- May 9, 2014
- Manufacturer
- OGDEN MANUFACTURING
- Product Code
- KDI
- PMA / PMN Number
- K082414
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A F/U REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.
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 LESS THAN 10CC'S. PT REQUIRED NO MEDICAL INTERVENTION. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307327 | OPTIFLUX F250NRE DIALYZER | KDI | OGDEN MANUFACTURING | 14AU02001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HEMODIALYSIS MACHINE |