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 05/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) - initial emdr submission.The sample has been requested from the customer.Awaiting for the sample to be returned.If any additional information becomes available, a follow up emdr submission will be sent.

Event Description

Specialty disposables- carefusion bubble humidifier reference number (b)(4), lot # tl1214001 was unable to be attached to the flowmeter due to cross threading.This was needed on a neonate in distress, with low saturations.This was a different flow meter as confirmed by the physician.Reported item was being used on patient.No patient harm or medical intervention reported.

Manufacturer Narrative

(b)(4).Follow up esubmission.Carefusion received three adaptors for evaluation.These adaptors were forwarded to the manufacturing site for evaluation.A test was conducted at the manufacturing site with the returned adaptors: adaptor failure to connect to airflow meter test: adaptor sample 1 - the adaptor easily threaded to a flowmeter.The adaptor did not look worn.Adaptor sample 2 - the adaptor appeared deformed due to usage; the threads felt tight.The adapter was easily threaded to a flowmeter.Adaptor sample 3- the adaptor easily threaded to a flowmeter.The thread on the adaptor felt tight.A comparative sample of (b)(4) adaptors (2 from each manufacturing cavity at the manufacturing site) of a recent lot number were obtained and connected to the same flowmeter.Cross threading was not observed on any of the 64 adaptors tested and all easily threaded on the flowmeter.Dimensional testing was also performed on adaptor sample 2 using a standard gauge and all testing met acceptance specifications.The investigation and analysis of the returned complaint devices could not replicate the customer¿s reported issue.All of the adaptors were successfully threaded to a flowmeter.The complaint devices evaluated were all found to be within all specifications.The reported issues will continue to be trended and monitored by carefusion.(b)(4).

• 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: 5650570
• MDR Text Key: 45037381
• Report Number: 2031702-2016-00598
• 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: 05/05/2016

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: TL1214001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention