Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
Inflammation (1932)
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Event Date 05/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported that excessive fluid went into the patient leg resulting in a fasciotomy.The pump was set at 40 and never indicated any change.The acl was completed with the same pump.Patient was a (b)(6) male.
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Manufacturer Narrative
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The complaint was not confirmed.The returned pump was visually inspected and showed no physical damage to the unit.Further review of the pump sub-assembly and components showed no issues with the latch door or tubing connector.The tubing sets used were not returned.The pump was assembled with a new ar-6410 tubing, and then tested and evaluated under normal use conditions to see if the issue(s) reported could be reproduced.The pump was powered on and function as intended with no error message and/or audible alarm triggered.
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Search Alerts/Recalls
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