CAREFUSION, INC ANES CIRCUIT, ADULT, 108 IN EXP, 2L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
|
Back to Search Results |
|
Catalog Number GNSFXXGX |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 10/04/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
At this time, the customer has not responded to requests for additional information regarding this event.If additional information becomes available, it will be submitted in a follow up report.At this time, carefusion has not received the suspect device/component for evaluation.(b)(4).
|
|
Event Description
|
It was reported by the customer that the green ventilator bag came flying off the machine during manual ventilation; it was after induction and after paralysis was initiated.There was no harm to the patient as quick action ensued.
|
|
Manufacturer Narrative
|
Follow up submission: samples were received for evaluation.The breathing bags were visually inspected.It was found that one of the breathing bags, part number r6049bba, the bushing was disconnected from the liter bag.The other breathing bag with the same part number was found with an incorrect assembly of the tape.In addition the bushing connector was dimensionally inspected and no issues were found.The incorrect assembly of the tape between the liter bag and the bushing could have contributed to the disconnected condition reported.Two years of complaints were reviewed and no trend was observed related to this issue.Based on the investigation, it was found that assembly personnel are related with the failure by not performing a proper assembly between the connections of the bushing and the liter bag with the tape.The white tape is part of the design to prevent a disconnection between these connections.To correct this issue, manufacturing personnel were retrained on the proper assembly of the connections with the white tape.In addition, the assembly instructions will be updated to included visual aides to help the manufacturing personnel when assembling this product.
|
|
Search Alerts/Recalls
|
|
|