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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCINNATI SUB ZERO HEMOTHERM HEATER/COOLER

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CINCINNATI SUB ZERO HEMOTHERM HEATER/COOLER Back to Search Results
Model Number 12/15/2015 - HPC CULTURE=26,000 CFU/ML
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/23/2015
Event Type  Malfunction  
Event Description

Per (b)(6) recently released guidance and recommendations for hospitals of (b)(6), we are reporting that 5 of our csz hemotherm hcu have tested above the epa standard (500 cfu/ml) as demonstrated by results of hpc cultures listed below.

 
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Brand NameHEMOTHERM
Type of DeviceHEATER/COOLER
Manufacturer (Section D)
CINCINNATI SUB ZERO
cincinnati OH 45241
MDR Report Key5332819
MDR Text Key34737166
Report NumberMW5058782
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 12/23/2015
5 DeviceS WERE Involved in the Event: 1   2   3   4   5  
0 PatientS WERE Involved in the Event:
Date FDA Received12/23/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number12/15/2015 - HPC CULTURE=26,000 CFU/ML
Was Device Available For Evaluation? No Answer Provided
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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