CAREFUSION, INC ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number A4UX2044 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/20/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Unfortunately, no sample was sent for evaluation.A lot number was not provided for evaluation.At this time it¿s not possible to review the device history record for any extraordinary event that could contribute to the defect reported.Based on similar complaints, the filter is ultrasonic welded together.It was noticed during assembly of this filter, that if the operator of the ultrasonic welder does not hold the button until the weld is complete the filter will not be welded completely.To correct and prevent this issue from continuing to occur, a sensor was installed on the welding machine, in order to have an automatic control on the finish of the welding cycle to alleviate the human factor of not pushing the button long enough.(b)(4).
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Event Description
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Filter has fallen apart during a case.It seems to be happening after the temperature of the filter has been equal to the patient's exhaled breath for a short time.
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Search Alerts/Recalls
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