MAUDE Adverse Event Report: CAREFUSION LIMBO CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number AFPXXXXXX

Device Problem Hole In Material (1293)

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

Event Date 03/14/2014

Event Type  malfunction  

Event Description

Limbo circuit had a significant hole in the septum that divides the exp/insp gases.Faculty circuit to be returned for investigation.

Manufacturer Narrative

(b)(4).Device evaluation anticipated, but has not yet begun.Upon carefusion's investigation, a follow up medwatch will be submitted.

Manufacturer Narrative

(b)(4).Correction: the correct sample receive date was updated to (b)(6) 2014.Investigation summary: one sample was returned for evaluation.Upon close examination under magnifying lens, a ½ inch diameter hole in the septum of the limb-o hose near the machine connector end was observed.Therefore, reported condition was confirmed.The device history record (dhr) is from january 25, 2011 and is stored off site.The dhr has been requested and will be reviewed upon receipt.However, a previous investigation completed showed that the reported condition is not related to final circuit assembly.This condition is considered to be related to the extrusion process of the limb-o tubing.During the manufacturing process review, it was observed that operative personnel did not execute the documented process (die pin cleaning) correctly.Based on the investigation, the most probable cause for the issue reported is due to the inadequate cleaning of the die-pin of the co-extruder.Please note that the lot reported was manufactured prior to corrective actions.Corrective actions included retraining operative personnel on the cleaning of the die-pin and frequency.Carefusion will continue to monitor and trend this issue.

• Brand Name: LIMBO CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION; vernon hills IL
• Manufacturer (Section G): VITAL SIGNS/CAREFUSION; 20 campus road; totowa NJ 07512
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3793131
• MDR Text Key: 21875852
• Report Number: 2242551-2014-00012
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,foreign
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AFPXXXXXX
• Device Lot Number: 11025-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1