MAUDE Adverse Event Report: CAREFUSION LIMB-O-CIRCUITS

Model Number AFPXXXXXX

Device Problems Hole In Material (1293); Tidal Volume Fluctuations (1634)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2014

Event Type  malfunction  

Event Description

Two approximate 5mm holes in internal septum of circuit allowed carbon dioxide from exhaled gases to mix with the inhaled gases, additional info received on 02/24/2014: we have received the following response to your questions about the limbo circuit fault, from specialist anaesthetist as follows: at what point before, during, or after the procedure was the problem with the limbo-o tubing detected: intraoperatively.If during, how far into use: post delivery, maintenance phase of an emergency general anaesthetic for caesarean section.How was the issue detected: machine alarms, changes in pt vital sings, visually, etc: carbon dioxide was detected in the inspiratory phase of the respiratory cycle on the capnogram.Soda lime was clearly not exhausted, the circuit valves appeared to be working normally.The specialist anaesthetist present worked out that there had to be a way for expiratory gas to be getting into the inspiratory limb of the circuit and went looking for faults in the septum while the anaesthetic continued.The defects in the septum were found visually.What was done to remedy the situation - circuit replaced, pt bagged w/manual resuscitator etc: circuit was replaced.This eliminated carbon dioxide from the inspiratory gases and allowed reduced fresh gas flows and tidal volumes.Prior to detection the trainee anaesthetist had used higher fresh gas flows and titrated ventilation to control the end tidal co2 concentrations.These were still high than ideal for the term pregnant pt.Was there any adverse pt outcome, pt harm or injury: no pt injury or harm.

Manufacturer Narrative

(b)(4).A retrospective review of all complaints post acquisition was performed.This complaint was identified as being mdr reportable by cfn standards and is being submitted to the fda.Upon carefusion's investigation, a follow up medwatch will be submitted.

• Brand Name: LIMB-O-CIRCUITS
• Type of Device: LIMB-O
• Manufacturer (Section D): CAREFUSION; 20 campus rd.; new jersey NJ 07512
• Manufacturer Contact: jill ritorno ; 75 n fairway dri; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3877629
• MDR Text Key: 15104165
• Report Number: 2242551-2014-00008
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AFPXXXXXX
• Device Lot Number: 7967601
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1