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MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03433)

MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03433) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MEDFUSION; Generic name: PUMP, INFUSION; Manufacturer: SMITHS MEDICAL ASD, INC..

DeviceMEDFUSION
Generic namePUMP, INFUSION
ManufacturerSMITHS MEDICAL ASD, INC.
Report number3012307300-2020-03433
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCONSUMER
NarrativeONE MEDFUSION PUMP WAS RECEIVED WITH A CRACK ON THE RIGHT PLUNGER CASE AND A MISSING PORTION OF THE BOTTOM CASE SEAL. THE EVENT HISTORY LOG WAS REVIEWED AND THERE WAS A FORCE SENSOR TEST ERROR. THE POWER UP PROCESS WAS CONDUCTED, THE FORCE SENSOR WAS ALSO CHECKED AND TESTED. A FORCE SENSOR ERROR WAS FOUND AT POWER UP AND THE FORCE SENSOR WAS UNABLE TO BE CALIBRATED. CONTAMINATION WAS FOUND INSIDE
SourceopenFDA MAUDE (device adverse events)

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