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MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03435)

MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03435) 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 number3012307300-2020-03435
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCONSUMER
NarrativeONE MEDFUSION PUMP WAS RECEIVED WITH BOTH FRONT CORNERS OF THE TOP CASE CRACKED, A CRACKED RIGHT PLUNGER CASE AND THE BOTTOM CASE WAS BADLY CRACKED. THE EVENT HISTORY LOG WAS REVIEWED AND THERE WAS A "PRIMARY AUDIBLE ALARM BACKGROUND TEST" MESSAGE. THE POWER UP PROCESS WAS CONDUCTED AND AN OCCLUSION TEST WAS PERFORMED. THE REPORTED ISSUE WAS UNABLE TO BE DUPLICATED AND THERE WAS NO DAMAGE TO THE I
SourceopenFDA MAUDE (device adverse events)

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