VYAIRE MEDICAL VITAL SIGNS GAS SAMPLING LINE, MULTIPATIENT, CONNECTOR, DISPOSABLE; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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Device Problem
Disconnection (1171)
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Patient Problems
Cardiopulmonary Arrest (1765); Hypoxia (1918)
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Event Date 01/24/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Vyaire has reached out to customer for additional information; however, no further information was available.An investigation could not be performed.If the customer provides product information or additional information, vyaire will provide a follow up emdr.
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Event Description
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It was reported to vyaire that there was a critical incident involving the disconnection of an (unknown part number) gas sampling line making correct placement of ett difficult to confirm.The customer states that the patient suffered hypoxia, airway obstruction, and cardio-respiratory arrest.Two cycles of cpr were given, 1mg adrenaline, reintubation eventually succeeded via bougie.Hypoxia lasting 3 - 5mins in total.Patient then stabilized whilst lightly anaesthetized.Decision was made to try to wake.Extubation then proceeded uneventfully with full recovery.The customer stated that an issue with the capnography line was identified.The capnography line was incorrectly connected and had sheared off making correct placement of ett difficult to confirm.The customer confirmed that no further patient harm was noted.
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Search Alerts/Recalls
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