MAUDE Adverse Event Report: CAREFUSION, INC CIRCUIT ADULT ANESTHESIA DELIVERY; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number A5U52XX4

Device Problem Torn Material (3024)

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

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial emdr submission-customer advocacy has reached out to customer to provide sample for the investigation.We have just recently received the affected sample.Once the investigation is complete or if we receive any additional information we will provide a follow up emdr.

Event Description

Customer reported via medwatch mw5059669 that he ventilated about twice and the breathing bag ripped apart.There was not harm to the patient.

Manufacturer Narrative

Cfn-(b)(4).Unfortunately the original complaint sample was not available for evaluation.The unopened samples that were submitted were tested using the following inspections: visual inspection, cycle test, concentricity test, leak test and also dimensional test of the thickness.The issue reported could not be confirmed with these samples.The device history record of the lot reported was evaluated for any issues, and no issues were found.Two years of complaints were reviewed from april 1, 2014 ¿ march 31, 2016 and no trend was observed.The manufacturing process has a 100% visual inspection, and the product must also pass the leak tester.In addition, our quality personnel perform a sampling with the following inspections: visual inspection, concentricity inspection, leak test and also dimensional inspection of the thickness.Without the original complaint sample available for evaluation it is not possible determine if the material is related to this failure.Based on the investigation, at this time it is not possible to determine a root cause for the issue reported.No corrective action will be implemented at this time without a confirmed root cause.

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.(b)(4).

• Brand Name: CIRCUIT ADULT ANESTHESIA DELIVERY
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION MEXICALI; cerrada vía de la producción n; pimsa iii, mexicali, b.c.; méxico ; MX
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628063
• MDR Report Key: 5463036
• MDR Text Key: 39484073
• Report Number: 2242551-2016-00030
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• 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,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A5U52XX4
• Device Lot Number: 0000865274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 112