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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN STOCKERT HEATER-COOLER SYSTEM 3T

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SORIN STOCKERT HEATER-COOLER SYSTEM 3T Back to Search Results
Lot Number PART #16-02-82
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 02/02/2016
Event Type  Malfunction  
Event Description

Sorin 3t machine grew out a mai from the water taken from the patient side port of the machine. Dates of use: (b)(6) 2013 - (b)(6) 2016. Reason for use: bypass surgery.

 
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Brand NameSTOCKERT HEATER-COOLER SYSTEM 3T
Type of DeviceSTOCKERT HEATER-COOLER SYSTEM 3T
Manufacturer (Section D)
SORIN
milan
IT
MDR Report Key5586817
MDR Text Key43029934
Report NumberMW5061763
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
Report Date 04/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/14/2016
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/29/2016
Device LOT NumberPART #16-02-82
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? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/14/2016 Patient Sequence Number: 1
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