MAUDE Adverse Event Report: CAREFUSION, INC HUMIDIFIER KIT 500ML 12/CS; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Catalog Number 002620-A

Device Problem Fitting Problem (2183)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4), initial emdr submission.The sample is available and is in the process of being investigated by the quality engineers.If any additional information becomes available, a follow up emdr submission will be sent.

Event Description

(b)(6) - had an incident report filed by our newborn nursery of a bubble humidifier that cross threaded and was not delivering oxygen to a baby.The humidifier was discarded, however another was pulled from the shelf and found to be impossible to thread correctly.The lot number is tl 121 4001.Patient had desaturation of 02 as stated by end user.On may 3, 2016, a medwatch was received by carefusion relating to this incident, medwatch number (b)(4).

Manufacturer Narrative

(b)(4).Follow up emdr submission.

• Brand Name: HUMIDIFIER KIT 500ML 12/CS
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): CAREFUSION, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): PISA FARMACEUTICA; calle 7 #1308, col. zona indus; 44940; guadalajara ja ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 5650504
• MDR Text Key: 45035150
• Report Number: 2031702-2016-00597
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K853146
• 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,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 002620-A
• Device Lot Number: TL 121 4001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA