Catalog Number 107640 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
Low Oxygen Saturation (2477); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/05/2021 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter phone number: (b)(6).Prismaflex st150 set has been temporarily approved for use in the us under emergency use authorization (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.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 internal blood leak was observed on two (2) units of a prismaflex st150 set during patient use.When treatment was started, the tests were ok and the patient was connected, however, later they observed that the blood was ending up in the effluent bag.A flow alarm and air alarm were triggered.The patient was disconnected and blood was not returned.A re-test of another kit on another machine was performed and again, blood was observed in the effluent at the patient's connection.The patient was disconnected without blood return.The patient experienced a progressive decrease in their hemoglobin level and a 3-4 hour delay in treatment.The customer could not provide the clinical symptoms as the patient was ¿resuscitating¿.No additional information is available.
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Manufacturer Narrative
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the actual device was not received; however, two companion samples were received for evaluation.A visual inspection and simulated test were performed and 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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