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

Model Number 2K8032

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4), emdr submission - one sample was received and evaluated.The failure reported was confirmed, the mask could only be removed from the device with great force.It was noticed during the evaluation that adhesive remains were found on the connection between the elbow and the mask.The elbow and the mask connections were dimensionally inspected and no issues were found.The device history record for the lot reported was evaluated for any issues related with this customer report.The product was manufactured, inspected and released in accordance with our internal procedures and no issues were observed.Two years of complaints were reviewed from january 1, 2015 - december 31, 2015 and no trend was observed.This product is assembled during stages.During the first stage of assembly, the mask is press fit onto the elbow of the device.During another stage, manufacturing personnel perform a connection between the oxygen connector and the part that connects to the flowmeter.During this stage an adhesive is used to secure the fit between these two components.If during this stage the mask disconnects from the elbow, the assembly personnel will press fit this piece into place.However, since this stage in the assembly process involves adhesive, there is a potential that adhesive can transfer onto the connection between the mask and the elbow from the hands of the assembly personnel.This would result in the failure that was reported.To correct and prevent this issue all production personnel were notified of this issue.In addition, if the mask becomes disconnected during assembly the device is to go back to the mask-elbow station to be reassembled, where this station does not use adhesive.This will alleviate the potential of transfer of adhesive from the hands of manufacturing personnel to the mask-elbow connection of the device.

Event Description

Customer stated via email: mask cannot be removed from manual resuscitator, which is necessary once patient is intubated.The end users usually take pliers to disconnect the mask.Patient was ventilated via the oral airway.Unable to provide info about the patient, patient did not sustain any injury/harm." the anesthetist and the inhalo they are using pliers to disconnect the mask from the device.Customer verified that the only lot that has this issue is 0000802624.

• Brand Name: RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS
• Type of Device: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): CAREFUSION; vernon hills; 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: 5666353
• MDR Text Key: 200811334
• Report Number: 8030673-2016-00152
• Device Sequence Number: 1
• Product Code: OEV
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2K8032
• Device Catalogue Number: 2K8032
• Device Lot Number: 0000802624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1