BAXTER HEALTHCARE - TIJUANA BAJA CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog Number 101025 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The actual device was not available for evaluation, however, eight retained samples were evaluated.Visual inspection and leak tests were performed.No anomalities were identified that could have contributed to the reported condition.The reported condition was not verified.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 cartridge bloodline, an external blood leakage was observed at the level of the arterial injection port.The blood was returned to the patient.Treatment was resumed using a new cassette without further reported issues.The blood loss was approximately 150ml.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Search Alerts/Recalls
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