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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. STOCKERT 3T HEATER COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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LIVANOVA USA, INC. STOCKERT 3T HEATER COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16S17157
Device Problem Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Fatigue (1849)
Event Date 11/12/2020
Event Type  Injury  
Event Description

Patient presented to our facility on (b)(6) 2020 with ongoing fevers and profound fatigue and was found to be positive for m. Chimaera. The patient has a history of ct surgery on (b)(6) 2017, with heater-cooler serial # (b)(4) used, and a subsequent ct surgery on (b)(6) 2018, with heater cooler serial # (b)(4) used. Manufacturer livanova was contacted and made aware of the infection. The machine used in the first surgery, serial # (b)(4), was on loan from the manufacturer that was also used on a second patient in our facility found to be m. Chimaera positive. We no longer have the loaner machine that was returned to the manufacturer on 5/20/2020. Test unit not on dropdown - molecules/microliter. Fda safety report id# (b)(4).

 
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Brand NameSTOCKERT 3T HEATER COOLER
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA USA, INC.
MDR Report Key11100361
MDR Text Key224766440
Report NumberMW5098576
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 12/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number16S17157
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/20/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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: 12/30/2020 Patient Sequence Number: 1
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