BAXTER HEALTHCARE CORPORATION PRISMAFLEX TPE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 114093 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Muscle Weakness (1967); Nausea (1970); Vomiting (2144); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/16/2022 |
Event Type
malfunction
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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 within the first few minutes of therapeutic plasma exchange with a prismaflex tpe2000, a blood leak detector alarm was triggered and an internal blood leak was identified.Visible blood tinged effluent was observed in the effluent line and the drain bag.Visible blood was also observed on the outside of the filter semi-permeable membrane fibers.Treatment was stopped without blood return.A total of 125ml of blood was lost.The patient was stable and the vital signs were normal.Within twenty (20) minutes of starting a new tpe treatment the patient became pale and presented with weakness, nausea and vomiting.The blood pressure reading was 84/43 mmhg.The patient was treated with an unspecified amount of saline.The patient reported they were not feeling well and treatment was interrupted with blood return and another 30 ml saline was provided.The patient 's condition subsequently improved, and the blood pressure increased to 110/60 mmhg.Tpe treatment was suspended for the day.No additional information is available.
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Manufacturer Narrative
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H10: the actual device was received for investigation.A pressure test was performed, no bubbling, no leak or entry of air was observed.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Additional information added to b1, h1 and h10.H10: based on additional information from device evaluation, and review of clinical circumstances surrounding the event, it is possible that the event of patient symptoms requiring medical intervention was associated with the previous blood loss in combination with underlying medical condition and applied treatment parameters when restarting the tpe treatment, therefore, it is unlikely that the prismaflex tpe 2000 caused or contributed to the serious event of patient symptoms.Based on additional information received, prismaflex tpe 2000 was determined not to be a factor in the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.
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