BAXTER HEALTHCARE CORPORATION PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 103453 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported this event to the fda through medwatch: (b)(4).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 treatment with a phoenix machine, a patient experienced a high ultrafiltration.It was reported that the patient's post weight was about 2.9 kg lower than the pre weight.The customer stated that the net ultrafiltration (uf) removed was 1.09l during dialysis.It was reported that the hemodialysis (hd) machine was showing d1-d2 error messages, reset the hd machine was performed and the d1-d2 error messages stopped showing.It was reported that in the last 45 minutes, d1-d2 error messages kept showing again and approximately 30 minutes remaining for treatment, the venous pressure went up to "300s".The customer decided to stop hd in order to prevent bloodline clotting and blood was returned to the patient.It was reported that the patient felt dry, however, their blood pressure was 129/73 mmhg.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 device was not received for evaluation; therefore, a device analysis could not be completed.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
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