MAUDE Adverse Event Report: TERUMO OXYGENATOR

Model Number FX15

Device Problem Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Date 01/13/2016

Event Type  malfunction  

Event Description

Oxygenator was being used in cabg, when it was noted it was not working properly.After oxygenator was replaced there appeared to be fiber "clots" in the device.

• Brand Name: OXYGENATOR
• Type of Device: OXYGENATOR
• Manufacturer (Section D): TERUMO
• MDR Report Key: 5393939
• MDR Text Key: 36983102
• Report Number: MW5059640
• Device Sequence Number: 1
• Product Code: DTZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FX15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other