MAUDE Adverse Event Report: CAREFUSION/BD RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS; MANUAL EMERGENCY VENTILATOR

Catalog Number 2K8032

Device Problem Disconnection (1171)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported "the tubing disconnect from the respirator.The oxygen tube that is inside the flex tubing, created this problem, looks like a bad connection inside.At first glance, nothing seems to be wrong with the bag, the outside of the bag look normal, but inside the flexible tubing, there¿s no oxygen that goes to the patient¿.They saw the spo2 dropping on the monitor for the patient and found the connection issue with the resuscitation bag".

Manufacturer Narrative

Device evaluation summary: representative sample was received for further evaluation.Per visual inspection the pvc tubing was disassembled from the resuscitator housing where solvent remnant was observed.The sample was not subject to a functional inspection (solvent effectiveness and pull test) due to its disassembled condition.Despite this a lack of solvent was observed at the tip of the pvc tubing and the o2 threaded housing.It is considered that the insufficiency of solvent between these two components could provoke the disconnection condition on the resuscitator.Therefore the reported failure mode was confirmed.After careful review of the entire manufacturing procedure based on the investigation findings it is probable that the disconnection reported could be related to the assembly personnel applying an inadequate amount of solvent during the assembly, and union of the pvc tubing and the housing, causing this incomplete assembly.Personnel have been retrained on this manufacturing procedure.

• Brand Name: RESUS,ADLT W/MSK,LRG TBG, P/O, 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: 6292485
• MDR Text Key: 66240617
• Report Number: 8030673-2017-00278
• 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: consumer,distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2K8032
• Device Lot Number: 0000802624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention