MAUDE Adverse Event Report: CAREFUSION/BD RESUS, ADLT W/MASK, 40" TBG, 6/CS; CARDIOPULMONARY RESUSCITATION AID KIT

Catalog Number 2K8005

Device Problem Disconnection (1171)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported the following directly to carefusion/bd "adapter/tube detached from coupler so the correct oxygen flow wasn't going to the patient.There was patient involvement, no patient harm".Carefusion/bd received medwatch report (b)(4).Customer reported ¿self-inflating ventilation bag was connected to oxygen source and patient was ventilated after intubation.The patient experienced decreasing oxygen saturation despite ventilation.Troubleshooting the issue revealed that the oxygen tubing had disconnected from the connection to the bag, which is inside a corrugated reservoir tubing.The patient was not receiving additional oxygen as intended.The equipment issue was found quickly, and new equipment was readily available, swapped out and the patient responded quickly there was no patient harm¿.

Manufacturer Narrative

Device evaluation: the sample was received and during visual inspection solvent was observed between the tubing and the threaded housing.It is considered that an insufficiency of solvent between these components provoked the disconnection of the resuscitator.Therefore the reported failure mode was confirmed.Based on the investigation it is considered that the root cause of the disconnection reported is related to the assembly personnel, not properly applying solvent at the union between the tubing and the housing.Personnel have been retrained on this manufacturing procedure.

• Brand Name: RESUS, ADLT W/MASK, 40" TBG, 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: 6524870
• MDR Text Key: 73785684
• Report Number: 8030673-2017-00327
• 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
• Type of Report: Initial,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• 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: 04/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2017
• 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