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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, STOKERT 3T HEATER COOLER

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LIVANOVA USA, STOKERT 3T HEATER COOLER Back to Search Results
Catalog Number 16-02-85
Device Problem Temperature Problem (3022)
Patient Problems Unspecified Infection (1930); Infection, Indirect (2245)
Event Date 05/09/2015
Event Type  Injury  
Event Description

A (b)(6) pt had heart valve replacement surgery on (b)(6) 2019. On (b)(6) 2019, pt was admitted with a diagnosis of mycobacterium avium intracellulare complex. On (b)(6) 2019, the diagnosis was changed to mycobacterium chimaera after a specialized lab was able to further differentiate this mycobacterium species. Pt was transferred to another facility for specialized treatment of this condition.

 
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Brand NameSTOKERT 3T HEATER COOLER
Type of DeviceSTOKERT 3T HEATER COOLER
Manufacturer (Section D)
LIVANOVA USA,
houston TX
MDR Report Key8560043
MDR Text Key143536568
Report Number8560043
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/18/2019,04/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/19/2019
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number16-02-85
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/18/2019
Distributor Facility Aware Date04/11/2019
Device Age4 yr
Event Location Hospital
Date Report TO Manufacturer04/19/2019
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/19/2019 Patient Sequence Number: 1
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