BAXTER HEALTHCARE CORPORATION AK 96 MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 114364 |
Device Problems
Fluid/Blood Leak (1250); Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/18/2023 |
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 an external fluid leak was observed in an ak 96 machine.During hemodialysis therapy, the nurse observed a silent photoelectric alarm), and immediately stopped the ultrafiltration contact equipment.After inspection, the hospital maintenance personnel determined that water was leaking from inside the machine, more specifically from the bottom of the internal water level sensor.Continuous water leakage would make the patient's ultrafiltration inaccurate and unable to achieve the expected treatment effect.There was no report of 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 actual device was not available; however, the device was evaluated on site by a non-baxter technician.During visual inspection the technician found a leakage from the dialyzer, specifically from the internal water level sensor (deairating chamber).The reported condition was verified.The component was replaced, and the machine was returned to service without any other problem.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
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