MAUDE Adverse Event Report: CAREFUSION MM10 SVN W TBG M/P TEE AND FLEX; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 002438-A

Device Problem Disconnection (1171)

Patient Problem No Code Available (3191)

Event Date 04/29/2015

Event Type  Injury  

Event Description

Customer stated via report "  multiple instances of inadvertent disconnection from wall or between the tubing and nebulizer itself have occurred, in the absence of patient movement.In one case, the patient was very compromised and the disconnection resulted in a code blue event.Lot number and sample are unavailable at this time.Email attached (b)(6) 2015 with additional info from customer- states product became disconnected "between neb and tubing", "no lot number available", treatment provided was "cpr/resuscitation", patient was on "6 liters" of oxygen prior to "code blue event".  a voicemail has been left with customer to gather additional info, awaiting response back.

Manufacturer Narrative

(b)(4) - to date a sample has not been received from the customer.Additional attempts have been made to contact customer, and sales rep met with respiratory therapy manager and no additional information has been provided by the customer.If any additional information becomes available a follow up mdr will be submitted.

Manufacturer Narrative

(b)(4).Follow up emdr submission- unfortunately, no sample was sent for evaluation.Therefore, the reported condition could not be confirmed.A lot number was not provided for evaluation.At this time it¿s not possible to review the device history record for any extraordinary event that could contribute to the defect reported.Without sample available for evaluation it¿s not possible to determine if personnel contributed to this failure, however the product is functionally tested prior to release to the public.Without lot available it¿s not possible to determine if material contributed to this issue reported.It is not considered that equipment is related to the failure mode.Based on the investigation, at this time it¿s not possible to determine a root cause for the issue reported on this product since the sample was not available for evaluation.No corrective actions will be implemented since the root cause could not be determined.Multiple attempts have been made by customer advocacy and the sales rep to gather additional information from the customer.However, the customer has not responded to any of these attempts.

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.(b)(4).

• Brand Name: MM10 SVN W TBG M/P TEE AND FLEX
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• 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 60061 ; 8473628056
• MDR Report Key: 4845022
• MDR Text Key: 5875445
• Report Number: 8030673-2015-00138
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 002438-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention