HOMECHOICE AUTOMATED PD SET WITH CASSETTE Adverse Event — Malfunction (MDR 1416980-2020-02435)
HOMECHOICE AUTOMATED PD SET WITH CASSETTE Adverse Event — Malfunction (MDR 1416980-2020-02435) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HOMECHOICE AUTOMATED PD SET WITH CASSETTE; Generic name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY; Manufacturer: BAXTER HEALTHCARE CORPORA
| Device | HOMECHOICE AUTOMATED PD SET WITH CASSETTE |
|---|---|
| Generic name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Report number | 1416980-2020-02435 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, CONSUM |
| Narrative | ADDITIONAL INFORMATION: H3, H6. H10: ONE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WITH THE NAKED EYE NOTED A BLACK PARTICULATE MATTER (PM) ON THE OUTSIDE OF THE TUBING AT THE TACK WELD. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE EVENT WAS DETERMINED TO BE MANUFACTURING RELATED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED |
| Source | openFDA MAUDE (device adverse events) |
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