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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP SORIN 3T HEATER COOLER SYSTEM

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SORIN GROUP SORIN 3T HEATER COOLER SYSTEM Back to Search Results
Catalog Number 16-02-82
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Death (1802); Fatigue (1849); Fever (1858); Respiratory Distress (2045); Chills (2191); Weight Changes (2607)
Event Date 11/02/2015
Event Type  Death  
Event Description

Patient had bioprosthetic aortic valve replacement and root repair with autologous pericardium on (b)(6) 2015. Sorin 31 heater cooler machine was used during his surgery. He developed 4 month complaint of fatigue, dry cough and weight loss, fever and chills in (b)(4) 2016. He was admitted to the hospital for work up on (b)(6) 2017 for suspect disseminated m chimera infection. Live biopsy was done and the culture from that grew out m chimaera along with urine. Patient decided to stop treatment and go home to die. Sent home on (b)(6) 2017 and did die.

 
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Brand NameSORIN 3T HEATER COOLER SYSTEM
Type of Device3T HEATER COOLER SYSTEM
Manufacturer (Section D)
SORIN GROUP
muchen, lindberg 80939 DE
GM 80939DE
MDR Report Key6475382
MDR Text Key72366748
Report NumberMW5068979
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
Type of Report Initial
Report Date 04/06/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number16-02-82
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?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/06/2017 Patient Sequence Number: 1
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