Model Number 2420-0007 |
Device Problems
Excess Flow or Over-Infusion (1311); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The customer¿s experience of an over infusion was neither confirmed nor replicated.¿the pcu event log contained no obvious programming errors that would result in the reported event.The log review indicates that the user set the vtbi to 50 mls and the device delivered the vtbi then alarmed for ¿infusion complete ¿ kvo¿ and was shut off.¿functional testing performed found the pump module to be delivering fluid within specification.¿there were no anomalies observed with the returned primary set (model 2420-0007) and there were no leaks observed from the set.¿the disposable set (model 2420-0007) was evaluated and was found to be slightly out of specification (0.001, and 0.002") however testing could not replicate the reported over infusion condition, therefore this is not believed to have contributed to the reported event.The starting/ending volume of the fluid container cannot be determined through device logs.
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Event Description
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Received a copy of the customer's medwatch report from fda which states, ¿amiodarone drip hung at 16.67ml/hr.Forty five (45) minutes later, entire 200ml bag was empty.Amiodarone 360mg in 200ccd5w - 0.5mg/min."although requested, no further details were provided by the customer for this event.
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Manufacturer Narrative
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The customer¿s experience of an overinfusion was neither confirmed nor replicated.The pcu event log contained no obvious programming errors that would result in the reported event.The log review indicates that the user set the vtbi to 50 mls and the device delivered the vtbi then alarmed for ¿infusion complete ¿ kvo¿ and was shut off.Functional testing performed found the pump module to be delivering fluid within specification.There were no anomalies observed with the returned primary set (model 2420-0007) and there were no leaks observed from the set.The disposable set (model 2420-0007) was evaluated and was found to be slightly out of specification (0.001, and 0.002") however testing could not replicate the reported over infusion condition, therefore this is not believed to have contributed to the reported event.The starting/ending volume of the fluid container cannot be determined through device logs.
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Event Description
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Received a copy of the customer's medwatch report from fda which states, ¿amiodarone drip hung at 16.67ml/hr.Forty five (45) minutes later, entire 200ml bag was empty.Amiodarone 360mg in 200ccd5w - 0.5mg/min."although requested, no further details were provided by the customer for this event.
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Search Alerts/Recalls
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