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U.S. Department of Health and Human Services

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

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SORIN GROUP USA INC. STOCKERT 3T HEATER-COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number UNKNOWN
Device Problem Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Granuloma (1876); Hepatitis (1897)
Event Date 06/18/2014
Event Type  Injury  
Event Description

Patient with history prostate cancer, thoracic aorta repair with aortic valve replacement 2 years ago, with insidious onset of illness with night sweats, weight loss, renal injury, mild transaminitis, splenomegaly, bilateral choroiditis, leukopenia, and anemia. Recently admitted about 2 months ago for about 3 weeks and liver biopsy during admission revealed acute hepatitis with granulomas. Two acid-fast bacillus (afb) blood cultures have turned positive recently. Patient was admitted with worsening renal function about a month ago. Patient underwent renal biopsy. Report of the renal biopsy appears to be consistent with acute interstitial nephritis (ain) (diffuse interstitial infiltrates, some giant cells - full report to follow). Acute kidney injury (aki) based on biopsy nephrology is concerned the patient is having ain and of his mediations rifampin seems to be the more likely culprit. Disseminated nontuberculous mycobacterial infection, suspected to be m. Chimaera, started on therapy 3 days after being admitted.

 
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Brand NameSTOCKERT 3T HEATER-COOLER
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP USA INC.
14401 west 65th way
arvada, co 80004 CO 80004
MDR Report Key6165950
MDR Text Key62109835
Report Number6165950
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 11/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/12/2016
Is This An Adverse Event Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberUNKNOWN
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/22/2016
Event Location Hospital
Date Report TO Manufacturer11/22/2016
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: 12/12/2016 Patient Sequence Number: 1
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