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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCINNATI SUB-ZERO, LLC. HEMOTHERM 400 CE CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER

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CINCINNATI SUB-ZERO, LLC. HEMOTHERM 400 CE CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER Back to Search Results
Model Number 86022
Device Problems Nonstandard Device (1420); Pumping Stopped (1503); No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/02/2017
Event Type  Malfunction  
Manufacturer Narrative

Csz medical technical support confirmed over the phone the device had no flow. The device was not flowing due to defective fuses. The user facility had a backup device that allowed the procedure to continue successfully. Medical technical support shipped new fuses per recall fa2017-010. The user facility replaced the fuses to resolve the issue. Based on this information, no further action is required.

 
Event Description

Cincinnati sub-zero received a report from the user facility stating the device stopped pumping during a procedure. The pump and heat light were illuminated and the device had no flow. The user facility had a backup device and the procedure was able to continue. There was no patient or user injury reported. This report was filed in our complaint handling system as (b)(4).

 
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Brand NameHEMOTHERM 400 CE
Type of DeviceCARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER
Manufacturer (Section D)
CINCINNATI SUB-ZERO, LLC.
12011 mosteller road
cincinnati OH 45241
Manufacturer Contact
christina miracle
12011 mosteller road
cincinnati, OH 45241
MDR Report Key6435941
MDR Text Key71213130
Report Number1516825-2017-00007
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK122813
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 03/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/27/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number86022
Device Catalogue Number400CE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/29/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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