BAXTER HEALTHCARE CORPORATION PRISMAX CONTROL UNIT; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 955626 |
Device Problem
Complete Loss of Power (4015)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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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 during continuous renal replacement therapy (crrt) with a prismax control unit, the unit shut down with an unrecoverable error.The treatment was ended without the extracorporeal blood being returned to the patient.The amount of blood loss was not reported.It was reported the hemoglobin level was below 7mg/dl.And the hematocrit was reported as "low".The patient received a blood transfusion (one unit of packed red blood cells).At the time of this report, the patient outcome was not reported.No additional information is available.
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Manufacturer Narrative
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Additional information added to h6 and h10.The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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