MAUDE Adverse Event Report: CAREFUSION/BD ANES CIRCUIT, ADULT, 72 IN CORR, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number AFNX2004

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) sample evaluation summary: one open sample was received for evaluation.Per visual the filter was found to be separated, and not welded.The reported failure was confirmed.The device history record of the lot reported in this incident was reviewed and no non-conformances related with the disconnected filter were observed.Two years of complaint rend were reviewed from july 1, 2014 to june 30, 2016 and no trend was observed.The possible root cause is due to equipment failure.An incomplete welding cycle could take place if the ultra-sonic weld button is un-pressed before the cycle is complete.There are missing controls to alert when the welding cycle isn¿t completed.A sensor was installed in the welding machine, in order to have an automatic control on the finish cycle.This will avoid operator error when removing hands before the cycle is completed.A test has been created to detect un-welded units.(b)(4).

Event Description

Customer reported "this circuit fell apart when turning patient prone the circuit disconnected from the patient.Went to reconnect when prone and it fell apart at the filter.We could not screw it together.Customer stated "as best as we can determine there was no patient harm.The physician tried other circuits until one worked.".

• Brand Name: ANES CIRCUIT, ADULT, 72 IN CORR, 3L BAG
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION/BD; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): CAREFUSION/BD; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 5843887
• MDR Text Key: 52182145
• Report Number: 8030673-2016-00197
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AFNX2004
• Device Lot Number: 0000883103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1