MAUDE Adverse Event Report: CAREFUSION, INC CAP/DIAPHRAGM SET,BOX OF 4,3100A_B; VENTILATOR, HIGH FREQUENCY

Catalog Number 766896

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial emdr submission.Awaiting for sample return from customer.If the sample is received from the customer the sample will be evaluated and tested.Additional information was requested from customer regarding the patient impacted with the desaturation.At this time we are still waiting for a response back from the customer.If additional information becomes available a follow up emdr will be submitted.

Event Description

Customer reported "getting water in the control and limit colored tubing while the 3100a units are running on patients.This is causing the map's to fluctuate while on patients.This has been happening since they started using the new style cap/diaphragms.They have to constantly get the water out of the lines etc.States there is no excess condensation in the circuits".Customer also states "desaturation has occurred related to the map fluctuating".

Manufacturer Narrative

(b)(4).Multiple attempts were made to gather the sample from the end user.The end user never sent the sample in to be tested.The results of the investigation are as follows.No sample was returned for evaluation.The device history record for the lot reported was reviewed and no issues were observed.At this time it is not possible to determine a root cause on the issue reported, since the sample was not provided for evaluation.At this time no corrective actions can be implemented, because we are unable to determine a root cause.However, manufacturing personnel were made aware of this issue.

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Additional information has been completed.Additional info: codes have been selected that represent the initial mdr submission.(b)(4).

• Brand Name: CAP/DIAPHRAGM SET,BOX OF 4,3100A_B
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION, INC; cerrada vía de la producción; no. 85., parque industrial mex; mexicali baja california norte ; MX
• Manufacturer (Section G): CAREFUSION, INC; cerrada vía de la producción; no. 85., parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 5584514
• MDR Text Key: 42887000
• Report Number: 8030673-2016-00160
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 766896
• Device Lot Number: 0000900156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 04/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/17/2016; 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other