MAUDE Adverse Event Report: CAREFUSION/BD ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number A9UX2XXX

Device Problem Disconnection (1171)

Patient Problems Awareness during Anaesthesia (1707); Hypoventilation (1916)

Event Date 02/27/2017

Event Type  Injury  

Manufacturer Narrative

It has been confirmed by carefusion/bd that the complaint sample is not available for evaluation.Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding the situation reported with the device.If a sample or any additional information becomes available a follow up emdr will be submitted.(b)(4).

Event Description

The customer reported that "the circuit leak was very large and i had to physically hold the system tightly together while waiting for the replacement, during which time ventilation and inhalational anesthetic administration was compromised.".

Manufacturer Narrative

No physical sample was provided for evaluation.The customer provided a photograph of the reported issue.However, a physical sample is needed to determine the root cause.2-years of complaints were reviewed and no trend was detected for this issue.At this time we are unable to determine a root cause since the physical sample was not provided.Despite this, our current manufacturing process and quality process was reviewed and no issues were found regarding the reported issue.

• Brand Name: ANES CIRCUIT, ADULT, 108 IN EXP, 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: 6443304
• MDR Text Key: 71165135
• Report Number: 8030673-2017-00308
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A9UX2XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: No
• 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