MAUDE Adverse Event Report: CAREFUSION CAREFUSION; CIRCUIT, BREATHING / CAI

Model Number INFANT FLOW LP SYSTEM

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 03/30/2015

Event Type  malfunction  

Event Description

The following description of the event was copied from an email from the representative of the user facility."i have a concern.We are currently using the sipap supplies and we have been having some issues with the headgear.They are having to change them out frequently due them being defected.It seems that the white piece that holds the prong or mask is coming apart.I have asked staff to solve the inserts that contain the lot numbers, but we have only been able to secure two.I have two lot numbers and they are 0000737207 and 0000728275.The 728275 was not used at all but the other one was used and luckily the insert was saved.I actually have 2 of the 3 in my office if you need to see them.".

Manufacturer Narrative

Carefusion has attempted to contact the user facility to request additional information and to request the return of the alleged faulty patient circuit component for evaluation.As of april 30, 2015 the user facility has not responded.

• Brand Name: CAREFUSION
• Type of Device: CIRCUIT, BREATHING / CAI
• Manufacturer (Section D): CAREFUSION; yorba linda CA
• Manufacturer (Section G): CAREFUSION; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: james stytle ; 7608837120
• MDR Report Key: 4747437
• MDR Text Key: 5884780
• Report Number: 2021710-2015-00885
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INFANT FLOW LP SYSTEM
• Device Catalogue Number: ASKU
• Device Lot Number: 0000737207
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2015
• 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