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ALARIS PUMP MODULE Adverse Event — Malfunction (MDR 2016493-2020-00694)

ALARIS PUMP MODULE Adverse Event — Malfunction (MDR 2016493-2020-00694) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ALARIS PUMP MODULE; Generic name: PUMP, INFUSION; Manufacturer: CAREFUSION SD.

DeviceALARIS PUMP MODULE
Generic namePUMP, INFUSION
ManufacturerCAREFUSION SD
Report number2016493-2020-00694
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCOMPANY REPRESENTATIVE, HEALTH
NarrativeIT WAS REPORTED FROM THE NURSEY UNIT THAT WHILE PROGRAMMING DEXTROSE 10% 250 ML INFUSION AT A RATE OF 110 ML/HR, IT WAS NOTED THAT THERE WAS NO LIMIT ALARM FOR THE NURSE. HOWEVER, IT WAS LATER NOTED ON THE IKP DATA THAT AN ALARM DID ALERT THE NURSE AND THE NURSE OVERRODE IT. PER USER, THE FOLLOWING GUARDRAILS PROGRAMMING LIMITS FOR DEXTROSE 10% INFUSION ARE: 2 ML/HR IS THE MINIMUM SOFT LIMIT, 40ML
SourceopenFDA MAUDE (device adverse events)

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