MAUDE Adverse Event Report: CAREFUSION/BD RESUS, PED W/MASK, LRG TBG, P/O, 6/CS; CARDIOPULMONARY RESUSCITATION AID KIT

Catalog Number 2K8018

Device Problem Failure to Disconnect (2541)

Patient Problems Apnea (1720); Low Oxygen Saturation (2477)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

Carefusion has received the complaint sample and is in the process of doing a full evaluation.Once the investigation is complete or if we receive any additional information we will provide a follow up emdr.(b)(4).

Event Description

Customer reported the following via medwatch report number (b)(4) "the patient had a desaturation episode to the 60's during a treatment.The respiratory therapist went to use the resuscitation bag and mask, but the mask size was wrong and it was not able to disconnect the mask from bag to switch to a different size.Customer confirmed that the mask was the wrong size for the patient but it was the mask that comes attached to the resuscitation bag the connector piece to the mask was stuck.The patient had an apneic event".

Manufacturer Narrative

One opened sample was returned for further evaluation.A visual inspection was performed and it was observed that the sample did not exhibit the textured surface finish on the connectors outer diameter.The textured surface makes it easier to detach the mask form the elbow.The prior design had a smooth mirror finish as exhibited on this sample.It was found that this mirror finish on the elbow and the smooth finish on the mask can create a vacuum effect making the removal of the mask difficult.A design change has been made to this product adding the texturized surface to the elbow eliminating the difficult remove failure mode.

• Brand Name: RESUS, PED W/MASK, LRG TBG, P/O, 6/CS
• Type of Device: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): CAREFUSION/BD; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): CAREFUSION/BD; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6491298
• MDR Text Key: 72778384
• Report Number: 8030673-2017-00321
• Device Sequence Number: 1
• Product Code: OEV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2K8018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2017
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention