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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 Problem
Bacterial Infection (1735)
Event Date
09/01/2013
Event Type
Injury
Event Description
Bloodstream infection with mycobacterium abscessus 2.5 months after left single lung transplant with cardiopulmonary bypass using 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
5319926
MDR Text Key
34239542
Report Number
MW5058675
Device Sequence Number
1
Product Code
DTR
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)
Hospitalization;
Patient Age
68 YR
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