Model Number UNKNOWN ENTERAL ACCESS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pneumothorax (2012)
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Event Type
Injury
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation but did not provide rationale.
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Event Description
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Customer reports: a swedish icu experienced an interface cable failure during a placement which unfortunately resulted in the nurse causing a pneumothorax.The safety team is performing an investigation to confirm who's at fault and if the interface cable has been identified as the cause.Per additional information received from the customer on 10/24/23, the clinical attempted to use the iris feeding tube, however prior to placement, there was no signal on the camera and the device could not be used.The customer stated they believe it was an issue with the interface cable.The clinician used another feeding tube and placed the device blindly which caused the pneumothorax.The clinician did not know if the feeding tube used was a cardinal health device.
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Manufacturer Narrative
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Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.
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Manufacturer Narrative
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Based on the additional information provided by the customer on 10/25/23, the clinician was unsure if the feeding tube that was used was a cardinal health device therefore the following fields were corrected: section d1: brand name - initially reported as iris interface cable has been updated to unknown enteral access feeding tube.Section d4: model number - initially reported as product code 388103 has been updated to unknown enteral access.Section d4: catalog number - initially reported as product code 388103 has been updated to unknown enteral access.Section d4: unique identifier - initially reported as (udi) #(b)(4) should be blank.
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Search Alerts/Recalls
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