Catalog Number 955626 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Low Blood Pressure/ Hypotension (1914)
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Event Date 11/16/2020 |
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 an excessive fluid removal occurred during continuous renal replacement therapy while using a prismax for the first time in the facility.Instead of entering a patient fluid removal (pfr) of 110 ml/hour the nurse set the total replacement of 1400 ml as pfr.The patient became hypotensive and norepinephrine infusion was titrated up to improve the patient 's blood pressure (bp).The physician was notified and the pfr was then set to zero since over 900 ml had been removed from the patient.The patient was drowsy but remained alert and oriented and on nasal cannula oxygen.The bp improved with pfr set at zero and increased norepinephrine dose.No additional information is available.
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Manufacturer Narrative
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Correction: removal of information in section f related to importer - the initial report inadvertently indicated that the report was being submitted as an importer report.This mdr should have been submitted only as a manufacturer report (and not as an importer report).
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Manufacturer Narrative
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Additional information: h6 and h10.H10: the device was not received for evaluation, however, the reported event of use error of entering the patient fluid removal value of 110 ml/hour instead of 1400 ml/hour was confirmed based on customer report.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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