SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number C45101796D-NL |
Device Problems
Break (1069); Moisture Damage (1405); Obstruction of Flow (2423); Moisture or Humidity Problem (2986); Output Problem (3005)
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Patient Problem
Respiratory Insufficiency (4462)
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Event Date 03/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D4: lot number, expiration date, udi number and h4: device manufacture date is unknown, no information has been provided to date.G5: 510k is blank device is exempt.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that the customer had issues with the anesthesia circuits that are currently in their circulation.Some have had cracks in the corrugated tubing itself, and some had issues with the dime zed filter in the circuit.The filter gets soaked with moisture and the thick sponge within the filter gets water logged and prevents medical staff from ventilating the patient.A 450lb patient with an unstable cervical spine fracture in the prone position, that suddenly stopped being ventilated due to the filter.
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Manufacturer Narrative
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No product was returned.We are unable to confirm the reported complaint.If the product is returned, icu medical will reopen this complaint for further investigation.A review of the device of the device history records could not be completed as no lot number was provided by the customer.
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Search Alerts/Recalls
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