OPTIFLUX 200NRE DIALYZER FINISHED ASSY. Adverse Event — Malfunction (MDR 1713747-2020-00173)
OPTIFLUX 200NRE DIALYZER FINISHED ASSY. Adverse Event — Malfunction (MDR 1713747-2020-00173) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: OPTIFLUX 200NRE DIALYZER FINISHED ASSY.; Generic name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE; Manufacturer: OGDEN M
| Device | OPTIFLUX 200NRE DIALYZER FINISHED ASSY. |
|---|---|
| Generic name | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE |
| Manufacturer | OGDEN MANUFACTURING PLANT |
| Report number | 1713747-2020-00173 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | PLANT INVESTIGATION: THE REPORTED COMPLAINT WAS NOT CONFIRMED AS THE COMPLAINT DEVICE WAS NOT RETURNED FOR MANUFACTURER EVALUATION. A PHOTO WAS PROVIDED BY THE CUSTOMER. THE PHOTO SHOWS THE TOP HALF OF THE DIALYZER, WHICH IS CONNECTED TO THE MACHINE, AND THERE APPEARS TO BE BLOOD AROUND THE FIBERS. A PRODUCTION RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. AN INVESTIGATION OF THE DEVICE HISTOR |
| Source | openFDA MAUDE (device adverse events) |
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