MAUDE Adverse Event Report: CAREFUSION/BD RESUS, ADLT W/MASK, 40" TBG, 6/CS; MANUAL EMERGENCY VENTILATOR

Catalog Number 2K8005

Device Problem Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2016

Event Type  Injury  

Manufacturer Narrative

Carefusion has reached out to customer to provide the complaint device for further investigation.The sample was received in a carefusion general office and forwarded to the carefusion manufacturing facility for further evaluation.Once an evaluation is completed then a supplemental report will be submitted.(b)(4).

Event Description

The customer reported that while trying to resuscitate an intubated patient, the mask on the bag would not come off the bag and they were unable to resuscitate the patient using the affected product.The customer stated they used another resuscitator with little delay.It was confirmed that there was no patient harm.

Manufacturer Narrative

Device evaluation summary: one sample was received for further evaluation.The unit was submitted to a functional inspection, and no issues related to the customers report were found; therefore the failure mode was not confirmed.The device history record was reviewed for the reported lot number and no issues related to the reported failure mode were found.The product was manufactured, inspected, and released in accordance with carefusion/bd internal procedures.Carefusion/bd did evaluate similar complaints based on trend; a probable root cause can be associated, even though the failure mode was not present in the provided sample.The probable root cause for the reported failure mode could be related to the current mirror finish surface on the elbow.This could make the mask very difficult to remove.A new brushed surface finish has been validated to eliminate this type of failure.Carefusion/bd has also retrained the assembly personnel on the assembly method between the elbow and the mask to ensure a correct press fit as an immediate containment action.A corrective and preventative action has also been opened on this reported failure to further investigate the root cause.

• Brand Name: RESUS, ADLT W/MASK, 40" TBG, 6/CS
• Type of Device: MANUAL EMERGENCY VENTILATOR
• 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: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 5936230
• MDR Text Key: 54193832
• Report Number: 8030673-2016-00224
• 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: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2K8005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention