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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.

DeviceCADD
ManufacturerSMITHS MEDICAL ASD, INC.
Report number3012307300-2020-03391
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceUSER FACILITY
NarrativeOTHER, 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.
SourceopenFDA MAUDE (device adverse events)

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