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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA (FORMERLY SORIN GROUP, S.P.A.) SORIN 3T PERFUSION HEATER-COOLER THERMAL REGULATOR DEVICE

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LIVANOVA (FORMERLY SORIN GROUP, S.P.A.) SORIN 3T PERFUSION HEATER-COOLER THERMAL REGULATOR DEVICE Back to Search Results
Model Number 3T
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Event Description

Sorin 3t perfusion heater-cooler tested positive for (b)(6). Hospital has not identified any related infections in pts. The device has been sequestered and disinfected pursuant to manufacturer recommendations and continues to receive recommended activities at recommended intervals. Microbiological sampling is being done continuously and passing results are pending.

 
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Brand NameSORIN 3T PERFUSION HEATER-COOLER
Type of DeviceTHERMAL REGULATOR DEVICE
Manufacturer (Section D)
LIVANOVA (FORMERLY SORIN GROUP, S.P.A.)
via benigono crespi, 17
milano 20159
IT 20159
MDR Report Key5620434
MDR Text Key44151442
Report NumberMW5061988
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
Type of Report Initial
Report Date 04/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/27/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3T
Device Catalogue Number16-02-85
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
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: 04/27/2016 Patient Sequence Number: 1
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