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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO HX2 HEATER COOLER

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TERUMO HX2 HEATER COOLER Back to Search Results
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 Key5319926
MDR Text Key34239542
Report NumberMW5058675
Device Sequence Number1
Product Code DTR
Reporter Country CodeUS
Number of Events Reported1
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 Received12/17/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age68 YR
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