MAUDE Adverse Event Report: CAREFUSION/BD ANES CIRCUIT, ADULT, 60 IN CORR, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number GAK1OXXX

Device Problem Crack (1135)

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

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Carefusion has received the complaint device and is currently performing an investigation into the reported issue.(b)(4).

Event Description

The customer reported that "the circuit passed a leak test but at the start of a case we could feel a huge leak.Reported item was being used on patient.No patient harm or medical intervention required".

Manufacturer Narrative

One open sample was received for evaluation.A visual inspection was performed and the separated/broken filter was confirmed.After a thorough evaluation of the manufacturing procedure it was found that the distance between the horn and the nest of the sortimat welding equipment was not checked at the beginning of production during line start up.An incorrect gap could cause an incomplete or weak weld of the filter.This lot number has been identified as pre-corrective action for the related capa.The corrective actions included an update to the manufacturing procedure to include verification of gap between the horn and nest to be performed at the shift start and with any lot change.Manufacturing personnel have been trained to include this procedure.

• Brand Name: ANES CIRCUIT, ADULT, 60 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: mindy faber ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6520644
• MDR Text Key: 73645046
• Report Number: 8030673-2017-00325
• 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,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GAK1OXXX
• Device Lot Number: 0001046880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 09/01/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention