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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
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 NameHX2 HEATER COOLER
Type of DeviceHX2 HEATER COOLER
Manufacturer (Section D)
TERUMO
MDR Report Key5319926
Report NumberMW5058675
Device Sequence Number1
Product CodeDTR
Report Source Voluntary
Reporter Occupation Physician
Report Date 12/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/17/2015 Patient Sequence Number: 1
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