Model Number 5301000 |
Device Problems
Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)
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Patient Problems
Overdose (1988); Electrolyte Imbalance (2196)
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Event Date 08/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is underway.A follow up report will be submitted after the investigation is completed.This is report 2 of 2 since the indicent allegedly occured with two patients.The first report was filed under report# 1649914-2020-00033.
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Event Description
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The report received states that over delivery of the potassium and additives were experienced during the first 2 cases with mps 3.This resulted in a hyperkalemic state for the patient that was able to be corrected on bypass by the perfusionist & anesthesiologists by giving insulin.
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Manufacturer Narrative
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The complaint sample was evaluated.Results from the investigation identified a software defect as the root cause of the reported complaint condition.The software was updated to ensure the device piston is left in its current position when flow is stopped instead of pulling the piston back to the relief position.Verification testing conducted on the updated software demonstrated the effectiveness of the change.The manufacturing process for the device was also updated to include multi-dose test cases.
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Search Alerts/Recalls
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