Catalog Number 107493 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Injury (2348)
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Event Date 09/25/2019 |
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 during continuous renal replacement therapy (crrt) using a prismaflex control unit, the patient experienced an increased calcium level.It was reported the treatment was performed for six days using regional citrate for anticoagulation and calcium was used via an external infusion pump.Crrt was discontinued due to another indication; however, the external calcium infusion was not stopped by the operator at the same time as crrt was stopped.The patient¿s ionized calcium reportedly increased, and an unreported medical intervention was required to treat the hypercalcemic condition.It was reported the event was resolved in 24-48 hours.No clinical symptoms were reported.No additional information is available.
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Manufacturer Narrative
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H10: the device was not returned for evaluation.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Based on available information, there was no evidence that a malfunction of the prismaflex caused the reported event.The reported event was caused by a user error as the external calcium infusion pump was not stopped when stopping the continuous renal replacement therapy.Regional citrate anticoagulation is not approved as anticoagulant method when using the prismaflex control unit with software 7.Xx and the control unit is therefore not designed to generate a notification to stop the calcium infusion when an external pumping device is used for calcium infusion.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction: removal of information in section f related to importer - the initial report inadvertently included the importer report number.This mdr should have been submitted only with the mfr.Number (and not as importer).
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Search Alerts/Recalls
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