BAXTER HEALTHCARE CORPORATION HD CARTRIDGE LINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog Number 103401 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/27/2023 |
Event Type
malfunction
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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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Event Description
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It was reported an external fluid leak was observed due to a ¿crack on the cartridge¿ of a gambro cartridge ext.Dialyzer during prime.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: the device was received for evaluation.During visual inspection, the arterial chamber of the cartridge was observed broken.A crack was identified from the inside of the chamber to the atmosphere, suggesting that the crack occurred inside to outside.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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