BAXTER HEALTHCARE CORPORATION PRISMAX CONTROL UNIT; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 955626 |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: pediatric patient.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) with a prismax machine v.2, the preset fluid loss/gain limit of 150 changed by itself to 400g/3h.No excessive fluid removal was reported as it was only the set alarm limit that had changed.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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H10: the event has been further evaluated and, as results, it has been concluded that the device malfunction do not have the likelihood to cause or contribute to death or serious injury.No excessive fluid removal was reported as only the set alarm limit that had changed.This issue only occurs when the operator enters a non-default value for the gain/loss limit setting during the initial setup, a filter change is made, and then the operator enters a change to the patient weight and/or hematocrit, in which case the gain/loss limit reverts to the default value.The prismax system monitors the patient fluid removed to protect the patient from fluid imbalance.Additional information is reported on the history screen including the unintended patient fluid gain, expressed as the accumulated fluid balance error within the last three hours.If the patient fluid removed is higher than the target value, there is an alarm for unintended fluid loss.If the patient fluid removed is lower than the target value, there is an alarm for unintended fluid gain.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the device was received for evaluation.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.Functional testing was performed, and service engineer was unable to duplicate the reported malfunction.A device history review revealed no issues that could have caused or contributed to the reported issue.Reviews of log files of previous similar events had shown that the reported condition occurs when the operator chooses to load the initial prescription settings from a profile, rather than enter each setting manually.After the treatment was started, at least one prescription setting change was made.The operator chose to end the treatment and use the same patient button to change to a new filter set (a filter set change must be done when the maximum treatment time for a filter has been reached).In addition, at least one prescription setting change was made after treatment was started again with the new filter set.In these conditions, the unintended change of the gain/loss limit occurred.The investigation concluded that the software was using the profile values outside the scope of setup (i.E.During treatment).Therefore, the cause of the prescription settings appearing to change without any direct manual entry is the software loading values from the profile, for display in the change dialog, rather than loading the current settings.Therefore, the root cause of this unintended behavior was that the design input was incompletely implemented.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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