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 periods.In all instances, extracorporeal blood was manually returned to the patient.Blood clots were observed, and the patients were transfused.No additional information is available.
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Manufacturer Narrative
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Additional information added to h3, h6 and h10.The actual device was evaluated on site by a biomedical technician.No overheating of the machines was confirmed, and no device malfunction was identified.The reported condition was not verified.The cause of the condition could not be determined; however, the most likely the cause was due to a ¿lack of nurse education¿.The unit where the issue occurred also "reflected it was nursing error".A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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