BAXTER HEALTHCARE - TIJUANA BAJA CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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Catalog Number 101025 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The device was not received for evaluation; therefore, a device analysis could not be performed.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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A patient undergoing dialysis treatment with a cartridge bloodline experienced an air in chamber alarm.Approximately two hours into treatment, the machine triggered an air in chamber alarm.The nurse tried and failed to remove the air, and upon further visual inspection, noticed the presence of a crack in the chamber with internal blood leakage.A blood loss of more than 150 ml was reported.Treatment was interrupted without returning the blood to the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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A batch review was conducted and there was no deviation 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 did not identify any abnormalities that could have contributed to the reported condition.Under water leak testing was performed, and no leaks were observed.Simulated use testing was performed with three retention samples, and it was determined that the sets could be loaded correctly, complete priming and treatment without leaks from the cartridge.No alarms were observed.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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