MAUDE Adverse Event Report: CAREFUSION/BD CIRCUIT, NEONATAL VOLUME VENT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number 155200EU

Device Problems Failure to Disconnect (2541); Connection Problem (2900)

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

Event Date 11/02/2016

Event Type  Injury  

Manufacturer Narrative

Carefusion/bd has reached out to customer to provide the complaint device for further investigation.The customer indicated that the sample was shipped back to carefusion/bd.A follow up mdr will be sent once the investigation has been completed.(b)(4).

Event Description

The customer reported that ¿the expiratory limb would not fit over the exhalation valve.The adapters that come on the ends of the circuit are sometimes the incorrect diameter to fit on certain machines.We take the adaptor off and replace it with the correct size for that particular transport machine.We transport a variety of patients on a variety of different ventilation machines.We have never had this issue before, we have always been able to remove the adapters.They are so stuck on now that we can¿t even pull them off with a hemostat.It is almost like they are glued on now.When transporting one patient we could not get the adaptor off, and we had to manually ventilate the patient with a resuscitation bag for the rest of the transport trip.There was no harm to the patient and no issues with ventilation during this time.".

Manufacturer Narrative

Follow up submission, investigation results: one sample was received for evaluation, during inspection the adapters that come on the end of the circuit were unable to be disconnected.The failure reported was confirmed.Two years of complaint data was reviewed for this product code, and no issues were observed relating to this failure.As part of the investigation, an interference analysis was performed between the end connectors, it was observed that both interfering parts have a different draft angle which can create a gap between both connectors.This gap can cause the two components to become stuck together.To correct this issue, the design of the connector will be evaluated to proceed with the change of the angle affected on the connection of the adapters.

• Brand Name: CIRCUIT, NEONATAL VOLUME VENT
• 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: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6134826
• MDR Text Key: 61139258
• Report Number: 8030673-2016-00263
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 155200EU
• Device Lot Number: 0001003043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2017
• 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