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

Catalog Number ADU520X4D

Device Problems Crack (1135); Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem Respiratory Distress (2045)

Event Date 12/21/2016

Event Type  Injury  

Manufacturer Narrative

This submission was deemed reportable based off of the investigation received on 21mar2017 on the one sample.One circuit sample was returned for evaluation, and a visual inspection was performed.The crack in the filter was observed; therefore the reported failure was confirmed.After reviewing the entire manufacturing procedure a probable root cause was identified.This cracked condition could have been caused by the pneumatic press machine.In the assembly area a pneumatic press is used to perform the assembly between the filter and the tubing.It was found that the press can cause similar cracks on the filter as the one reported within this complaint if the filter is not aligned properly between the pistons.A filter holder would ensure the correct alignment.The alignment between the pistons and the tube nest was found out of alignment.Corrective and preventative actions include pneumatic press machine maintenance to align the pistons, and the new designed filter holder.

Event Description

Customer reported that the circuit was leaking due to a crack on the filter.The initial pressure test was successful but eventually the leak manifested and alarmed the patient was bagged and the circuit was switch.It was difficult to determine the source but after inspection, the hairline crack was found.The ventilator did alarm as intended the situation was controlled and the circuit was changed out with no harm to the patient.

• 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: 6494198
• MDR Text Key: 72842474
• Report Number: 8030673-2017-00322
• 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
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ADU520X4D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2017
• 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