Catalog Number 2C8750 |
Device Problems
Backflow (1064); No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that an unspecified quantity of clearlink system y-type blood/solution sets did not function.This was observed during an unspecified process step.For this event, the tubing has no backflow valve, so blood backs up in the chamber when the blood pressure cuff was inflated.This frequently creates an airlock and then blood will not flow unless put under pressure.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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Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Additional information was added to h6 and h10: h10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Correcting the following fields to align with the information provided in the global unique device identification database (gudid): d1: brand name, d3: device manufacturer name, d4: model #, d4: unique identifier (udi) #, g4: combination product.The d4: unique device identifier (udi) # is based on the di information as no lot/serial number was provided by the reporter.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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