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ALARIS PUMP MODULE ADMINISTRATION SET Adverse Event — Malfunction (MDR 9616066-2020-01477)

ALARIS PUMP MODULE ADMINISTRATION SET Adverse Event — Malfunction (MDR 9616066-2020-01477) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ALARIS PUMP MODULE ADMINISTRATION SET; Generic name: SET, ADMIN, INTRAVASCULAR.; Manufacturer: CAREFUSION.

DeviceALARIS PUMP MODULE ADMINISTRATION SET
Generic nameSET, ADMIN, INTRAVASCULAR.
ManufacturerCAREFUSION
Report number9616066-2020-01477
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCOMPANY REPRESENTATIVE, HEALTH
NarrativeIT WAS REPORTED FROM THE PHARMACY ROOM THAT PRIMARY TUBING SETS SEPARATED AT THE PUMP SEGMENT AND THAT IT "APPEARS TO BE HAPPENING WITH THE SAME BATCH OF PRODUCT." THIS WAS HAPPENING BEFORE THE PRODUCT WAS TO BE USED ON A PATIENT, SO THERE IS NO PATIENT INVOLVEMENT.
SourceopenFDA MAUDE (device adverse events)

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