CADD Adverse Event — Malfunction (MDR 3012307300-2020-03391)
CADD Adverse Event — Malfunction (MDR 3012307300-2020-03391) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CADD; Manufacturer: SMITHS MEDICAL ASD, INC.; Report number: 3012307300-2020-03391.
| Device | CADD |
|---|---|
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Report number | 3012307300-2020-03391 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | USER FACILITY |
| Narrative | OTHER, OTHER TEXT: ADDITIONAL INFORMATION: D10. DEVICE EVALUATION: ONE CADD SOLIS VIP PUMP WAS RETURNED FOR ANALYSIS IN GOOD CONDITION. A VISUAL INSPECTION AND A FUNCTIONAL CHECK WAS PERFORMED. THE CUSTOMER'S REPORTED PROBLEM WAS CONFIRMED. THE ANALYSIS REVEALED A BUBBLED DOWNSTREAM OCCLUSION SENSOR SEAL. THE DOWNSTREAM OCCLUSION SENSOR SEAL WILL BE REPLACED TO RESOLVE THE ISSUE. |
| Source | openFDA MAUDE (device adverse events) |
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