BAXTER HEALTHCARE CORPORATION PRISMAX MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 955626 |
Device Problem
Overheating of Device (1437)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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 that "overheating" of a prismax machine was observed after being used for extended time periods.It was further reported the staff tried to return the blood manually, however ¿most of the times the blood clots¿ and the patient needed a blood transfusion.No additional information is available.
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Manufacturer Narrative
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Additional information added to h3, h6 and h10.The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.The actual device was evaluated on site by a local hospital engineer.No overheating of the machines was confirmed.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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