MAUDE Adverse Event Report: CAREFUSION, INC RESUS, ADLT W/MASK, RESV BAG, 6/CS; CARDIOPULMONARY RESUSCITATION AID KIT

Model Number 2K8004

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Hypoxia (1918); Low Oxygen Saturation (2477)

Event Date 01/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial emdr submission.It has been confirmed the complaint sample is not available for evaluation.Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding situation reported with device.Customer advocacy is still waiting for additional information regarding reported issue.If a sample or any additional information becomes available a follow up emdr will be submitted.

Event Description

The end user stated via email "pt was in the gi lab for an egd.Once procedure was complete the pt started to desaturate and dr.(b)(6) requested an ambu bag.Once the ambu bag was obtained and placed over the patients mouth and nose and was hooked up to oxygen, the patient continued to desaturate.Dr.(b)(6) was working the ambu bag and seemed to be working normally but the patient still was not getting any better.She was squeezing the bag to assist the patient with his breathing and still nothing was working.When the patients oxygen saturation was 32%, i went to get another bag and at the point the patients saturations started to come back up.Dr.(b)(6) was still assisting the patient with his breathing by squeezing the bag and this time it seemed to working and the oxygen return bag was filling up showing us that the patient was breathing at this time.This all took place within about 3-5 minutes.After the patient's oxygen saturation was in the middle 90's the patient was sent to recovery.It was confirmed that there was no harm.

Manufacturer Narrative

(b)(4).Unfortunately, no sample was sent for evaluation and without the lot number available it is not possible to review the batch history record to search for any extraordinary event that could contribute to the defect reported.Two years of complaints were reviewed from march 1, 2014 - february 29, 2016 and no trend was observed.Without the sample it¿s not possible determine if personnel contributed to this failure.Current product line is running according to procedure.Our quality personnel perform a sampling with a visual and functional inspection according to procedure of inspection.No issues were found with the materials.It is not considered that equipment is related to the failure mode, and no issues were found with the design.Based on the investigation, at this time it¿s not possible to determine a root cause for the issue reported on product since the sample was not available for evaluation.At this time no corrective action will be implemented, since the defect could not be confirmed.

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: RESUS, ADLT W/MASK, RESV BAG, 6/CS
• Type of Device: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION CORP; cerrada via de la produccion #; parque industrial mexicali iii; mexicali b.c 21397 ; MX 21397
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628063
• MDR Report Key: 5463611
• MDR Text Key: 39147798
• Report Number: 8030673-2016-00156
• Device Sequence Number: 1
• Product Code: OEV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2K8004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention