2008T HEMODIALYSIS SYS., WITH CDX Adverse Event — Malfunction (MDR 2937457-2020-00748)
2008T HEMODIALYSIS SYS., WITH CDX Adverse Event — Malfunction (MDR 2937457-2020-00748) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 2008T HEMODIALYSIS SYS., WITH CDX; Generic name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE; Manufacturer: CONCORD MANUFACTURI
| Device | 2008T HEMODIALYSIS SYS., WITH CDX |
|---|---|
| Generic name | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE |
| Manufacturer | CONCORD MANUFACTURING |
| Report number | 2937457-2020-00748 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | USER FACILITY |
| Narrative | PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION WAS PERFORMED BY A FRESENIUS FIELD SERVICE TECHNICIAN (FST). A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIF |
| Source | openFDA MAUDE (device adverse events) |
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