MAUDE Adverse Event Report: CAREFUSION TRANSFER SET RESPIRATORY 48/CS; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 2C7103

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 04/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial submission- multiple attempts have been made by customer advocacy and sales rep to obtain additional information.Customer has not responded to any attempts to date.The complaint description states that a sample and photos are available for evaluation.A (b)(6) shipping label has been provided to the customer for sample return.However, per the (b)(6) tracking number the sample has not been sent to date.The complaint states that the sample is with the customer's risk management personnel.If a sample becomes available a full evaluation will take place.If any additional information becomes available a follow up mdr will be submitted with all information.

Event Description

The following was reported to carefusion by sales rep stating "while it was on an infant at 4 l liters even though it was clamped off somehow it leaked.The  infant got lavaged with the water that filled the water chamber and circuit and the patient respiratory arrested.The infant was stabilized.Customer does not have packaging.She has the bag and feed set however isn't able to get it to us yet per risk management.Anne has photos and the product." (b)(6) 2015- phone conversation with sales rep (b)(6).  states the feed set was hooked up to product code mr850 heater fisher & paykel.  also, states will follow up with customer to get additional information regarding the incident that occured.

• Brand Name: TRANSFER SET RESPIRATORY 48/CS
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): CAREFUSION; vernon hills; illinois; il
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no85parque indust.mexicali iii; mexicali, 21600 ; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, il
• MDR Report Key: 4782591
• MDR Text Key: 191870651
• Report Number: 8030673-2015-00135
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS II
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 2C7103
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention