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 machines 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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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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