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MAUDE Adverse Event Report: TERUMO HX2 HEATER COOLER
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TERUMO HX2 HEATER COOLER
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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.
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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
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
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
12/17/2015
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
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