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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC BIO/CAL 370 SN HEATER/COOLER

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MEDTRONIC BIO/CAL 370 SN HEATER/COOLER Back to Search Results
Model Number BIO/CAL 370 SN
Device Problems Microbial Contamination of Device (2303); Device Contamination with Chemical or Other Material (2944)
Patient Problems Abscess (1690); Bacterial Infection (1735); Death (1802)
Event Date 12/12/2014
Event Type  Death  
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Brand NameBIO/CAL 370 SN HEATER/COOLER
Type of DeviceBIO/CAL 370 SN HEATER/COOLER
Manufacturer (Section D)
MEDTRONIC
minneapolis MN 55432
MDR Report Key5080660
Report NumberMW5056170
Device Sequence Number1
Product Code DWJ
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/11/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2015
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberBIO/CAL 370 SN
OTHER Device ID NumberAK1488
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

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