Catalog Number 2H7462 |
Device Problems
Device Displays Incorrect Message (2591); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that an unspecified quantity of clearlink secondary medication sets had collapsed tubing causing upstream occlusion alarms on the infusion pump.It was further reported that on other occasions the roller clamps compressed the tubing and the tubings did not come back to the initial form causing occlusions.This was noted during patient infusions.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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The actual devices were not available; however, a photograph of one (1) sample was provided for evaluation.Visual inspection on the photograph revealed a damaged chamber.No functional test was performed due to the nature of the sample.The reported condition was verified on the one (1) sample through photo inspection.The cause of the condition is related to the material during manufacturing.Additional samples were not returned; therefore a device analysis could not be completed for those samples.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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