BAXTER HEALTHCARE CORPORATION CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog Number 101025 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Event date: the event occurred on an unspecified date in (b)(6) 2021.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 during treatment with a gambro cartridge, an arterial pressure alarm was generated and an external blood leak was observed.The location of the blood leak and the amount of blood loss were not specified.The treatment was ended without the restitution of blood contained in the extracorporeal circuit.There was no patient injury or medical intervention associated with this event.No additional information is available.
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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.The cause was attributable to the manufacturing and assembling process.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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