MAUDE Adverse Event Report: SECHRIST INDUSTRIES OXYGEN AIR PROPORTIONER

Model Number 3500

Device Problems Failure to Deliver (2338); Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 02/18/2014

Event Type  malfunction  

Event Description

Upon initiating cardiopulmonary bypass the patient was observed to not be receiving oxygen.The room source was checked and oxygen was being delivered.The source of the defect was the oxygen blender located on the heart-lung machine.The blender was reading as though it was working correctly, but blood gas and observation found the patient was not getting supplemental oxygen.The machine was immediately removed from service.

• Brand Name: OXYGEN AIR PROPORTIONER
• Type of Device: OXYGEN AIR PROPORTIONER
• Manufacturer (Section D): SECHRIST INDUSTRIES; alameda CA 92807
• MDR Report Key: 3667634
• MDR Text Key: 4344439
• Report Number: MW5034826
• Device Sequence Number: 1
• Product Code: BZR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2014

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: 3500
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR