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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP, LIVANOVA STOCKERT SORIN GROUP (NOW LIVA NOVA) STOCKERT, 35 HEATER-COOLER

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SORIN GROUP, LIVANOVA STOCKERT SORIN GROUP (NOW LIVA NOVA) STOCKERT, 35 HEATER-COOLER Back to Search Results
Model Number 3T
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem Unspecified Infection (1930)
Event Type  Malfunction  
Event Description

Despite strict compliance with manufacturer recommendations for cleaning, the sorin heater-cooler unit used during the performance of open heart surgery tested positive during routine culturing of equipment for (b)(6). This may have exposed the pts to a potential source of infection.

 
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Brand NameSORIN GROUP (NOW LIVA NOVA)
Type of DeviceSTOCKERT, 35 HEATER-COOLER
Manufacturer (Section D)
SORIN GROUP, LIVANOVA STOCKERT
lindberghstrasse 25
munchen 80939
GM 80939
MDR Report Key5725534
MDR Text Key47423376
Report NumberMW5062865
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3T
Was Device Available For Evaluation? Yes
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: 06/13/2016 Patient Sequence Number: 1
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