BAXTER HEALTHCARE CORPORATION HD CARTRIDGE LINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog Number 103401 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2024 |
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 that an external fluid leak was observed from a gambro cartridge during priming.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 of the actual device, a crack in the arterial chamber was observed which would have allowed the leakage event.Eight (8) retention samples were inspected and did not identify any abnormalities that could have contributed to the reported condition.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the crack was not determined.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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