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Catalog Number 1C8160 |
Device Problems
Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
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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 there was a hole in the tubing of three (3) solution sets which resulted in a leak.This issue occurred when chemotherapy was being hung and the tubing was inserted into the pump.Liquid vigorously sprayed out.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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G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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