HOMECHOICE CYCLER-REFURBISHED Adverse Event — Malfunction (MDR 1423500-2008-00083)
HOMECHOICE CYCLER-REFURBISHED Adverse Event — Malfunction (MDR 1423500-2008-00083) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HOMECHOICE CYCLER-REFURBISHED; Generic name: 78FKX; Manufacturer: BAXTER HEALTHCARE.
| Device | HOMECHOICE CYCLER-REFURBISHED |
|---|---|
| Generic name | 78FKX |
| Manufacturer | BAXTER HEALTHCARE |
| Report number | 1423500-2008-00083 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-14 |
| Report source | Consumer, Company representation |
| Narrative | A HOME PT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER ON (B)(6) 2007 TO REPORT FEELING OVERFILLED DURING PERITONEAL DIALYSIS THERAPY ON A HOME CHOICE DEVICE. DURING EVALUATION OF THE PT'S HOMECHOICE, A BAXTER TECHNICIAN IDENTIFIED AN ADD'L POTENTIAL OVERFILL SITUATION. THE PT'S ULTRAFILTRATION (UF) FOR CYCLE 4 OF THERAPY ON (B)(6) 2007 WAS 716ML, INDICATING THAT THE PT DRAINED 716ML MORE THAN THE |
| Source | openFDA MAUDE (device adverse events) |
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