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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN SORIN WATER HEATER/COOLER

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SORIN SORIN WATER HEATER/COOLER Back to Search Results
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem Bacterial Infection (1735)
Event Type  Malfunction  
Event Description

Routine lab testing of sorin water heater/cooler machine revealed the presence of ntb. On (b)(6) 2016; 40 cfu/ml of mycobacterium chimaera isolated.

 
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Brand NameSORIN WATER HEATER/COOLER
Type of DeviceSORIN WATER HEATER/COOLER
Manufacturer (Section D)
SORIN
MDR Report Key5962756
MDR Text Key55259501
Report NumberMW5064834
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 09/16/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/16/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
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

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