MAUDE Adverse Event Report: TERUMO HX2 HEATER COOLER

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Pseudoaneurysm (2605)

Event Date 11/24/2014

Event Type  Death  

Event Description

In (b)(6) 2014 developed mycotic aortic arch pseudoaneurysm with mycobacterium abscessus 2.5 years after orthotopic heart transplantation using cardiopulmonary bypass (cpb) with terumo hx2 heater cooler.

• Brand Name: HX2 HEATER COOLER
• Type of Device: HX2 HEATER COOLER
• Manufacturer (Section D): TERUMO
• MDR Report Key: 5317565
• MDR Text Key: 34238896
• Report Number: MW5058640
• Device Sequence Number: 1
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR