SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX HEAT AND MOISTURE EXCHANGE FILTER, ELECTROS; FILTER, BACTERIAL, BREATHING-CIRCUIT
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Model Number 62.002.0090.9064/711CRSA |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Type
Death
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
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Event Description
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It was reported that "an accident occurred when this product was used in combination with a humidifier." the product was used in combination with a heating humidifier and a medical incident occurred during the use of it.This is an investigative inquiry from the police in the jurisdictional area, and details are unknown.Pre-use check was not clear.Disinfection and sterilization status were unknown.The following additional information was provided on (b)(6) 2022: the patient was in their 70s and had a tracheotomy tube.Also, the patient was using a heating humidifier under the control of an artificial respirator.After the patient took a bath, the breathing circuit was re-connected, and then, the healthcare worker left the patient's side.After that, the patient was found dead in the hospital room.The healthcare worker noticed an hme filter was attached to the breathing circuit, which had not been used before bathing.The cause of death is unknown.
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Manufacturer Narrative
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Other, other text: no lot number was provided; therefore, device history record review could not be performed.No product sample was received and there was no evidence showing the defect; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If evidence is made available, the investigation will be reopened., corrected data: d4: device lot number is unknown.
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Manufacturer Narrative
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Other, other text: corrected data h1, corrected data: corrected data h1 death.
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Search Alerts/Recalls
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