Model Number 2429-0500 |
Device Problems
Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Information (3190)
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Event Date 04/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
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Event Description
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It was reported that the tubing set had a hole in it and leaked.
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Manufacturer Narrative
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The customer¿s report of a tubing set with a hole and leak was confirmed and replicated during testing.During visual inspection, it was observed immediately that the pvc tubing had a slice cut approximately 5 ½ inches below the drip chamber.The slice cut was measured to be 0.13" inches long.Functional testing was performed by attaching the set to a bag filled with tap water and allowing fluid to flow through the set via gravity.A leak was immediately observed from the slice cut in the pvc tubing.The root cause of the slice cut was not identified.
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Event Description
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It was reported that the tubing set had a hole in it and leaked.
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Search Alerts/Recalls
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