BAXTER HEALTHCARE CORPORATION CARTRIDGE; 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 Consequences Or Impact To Patient (2199)
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Event Date 05/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address: (b)(6).Phone number: (b)(6).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 approximately about three hours and 40-50 minutes after starting dialysis treatment with a gambro cartridge set, an external blood leak was observed from the venous patient connector.The volume of the blood loss was not reported.The treatment was stopped and the extracorporeal blood was returned to the patient.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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The actual device was not available; however, two photographs were provided for evaluation.The inspection of the photographs and eight retained samples did not verify 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.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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