Catalog Number 955606 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Air/Gas in Device (4062)
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Patient Problem
Air Embolism (1697)
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Event Date 10/29/2022 |
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 a patient experienced an air embolism when performing a fast recovery with the main switch on an ak 98 machine while performing therapy at home.The machine generated several alarms (of unknown type) during the treatment, including ¿air in the venous drip chamber alarm¿.The patient tried to perform a manual blood return for an unknown reason and because the venous line was clamped, the patient shut down the machine at the main switch at the back.By the time the machine recovered (a few seconds), the venous clamp opened and due to a high venous pressure, the air in the circuit entered directly to the patient.The patient was transferred to a hospital for hyperbaric chamber treatment.At the time of this report, the patient has recovered.No additional information is available.
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Manufacturer Narrative
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H10: the device was evaluated on site by a qualified technician and found working as per specifications.Based on log file analysis, the reported condition was not verified.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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Manufacturer Narrative
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Based on additional information received, the ak98 machine 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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Search Alerts/Recalls
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