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Catalog Number MP01805 |
Device Problems
Complete Blockage (1094); Mechanical Problem (1384); Obstruction of Flow (2423)
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Patient Problem
Hypoxia (1918)
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Event Date 09/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is still on-going.The results will be provided with a follow-up report.
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Event Description
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It was reported that the filter clogged during the first nebulization.Due to the massive occlusion, it was no longer possible to ventilate the patient, who became hypoxic and required resuscitation.After changing the filter, the patient's condition improved abruptly.
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Manufacturer Narrative
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According to the event description, medication nebulization was performed during ventilation when using the twinstar 55 filter.The instructions for use of the hme twinstar filter used describe as a warning that it should not be used in combination with active humidifiers or medication nebulizers, as there is a risk of pressure build-up and inadequate ventilation of the patient.In the present case, nebulization was carried out in combination with the filter contrary to the instructions for use, so that the filter was blocked and it was consequently no longer possible to ventilate the patient.When the filter is closed, the airway pressure increases as a result.This is detected by the connected device and a corresponding alarm is issued as soon as set alarm limits are reached.The number of comparable cases, related to the root cause (user error), is within the expected range of the respective risk assessment and thus accepted.
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Event Description
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It was reported that the filter clogged during the first nebulization.Due to the massive occlusion, it was no longer possible to ventilate the patient, who became hypoxic and required resuscitation.After changing the filter, the patient's condition improved abruptly.
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Search Alerts/Recalls
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