Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/16/2021 |
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 the pump went into turbo mode and dispersed excessive fluid into the shoulder.The pump was replaced and the same event started to occur.The patient had to be admitted for an overnight stay.
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Manufacturer Narrative
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The complaint was not confirmed.The returned pump was visually inspected and showed scratches at the top housing on the unit.Further review of the pump sub-assembly and components showed no issues with the latch door or tubing connector.Tub set was not returned for evaluation.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.Among the most common causes for this type of issue/occurrence are (1) unplugging and plugging the pressure line connector into the arthroscopy pump, thereby creating a pressure decay on the pump or (2) spiking the bags of fluid and allowing that fluid to migrate through the tubing before plugging the pressure line connector into the pump.
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Search Alerts/Recalls
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