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MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03424)

MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03424) 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 number3012307300-2020-03424
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCONSUMER
NarrativeONE MEDFUSION PUMP WAS RECEIVED WITH THE TOP CASE CRACKED AND CHIPPED. THE BOTTOM CASE HAD SEAL DAMAGE. THE EVENT HISTORY LOG WAS REVIEWED AND THERE WAS A CONFIGURATION ERROR AT START-UP. SOME OF THE KEYS ON THE KEYPAD DID NOT WORK. A START-UP TEST WAS CONDUCTED AND THE REPORTED ISSUE WAS ABLE TO BE REPLICATED. THE PUMP NEEDED TO BE UPLOADED FROM THE BOTTOM CASE. THE ISSUE WAS USER INDUCED AS THE
SourceopenFDA MAUDE (device adverse events)

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