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U.S. Department of Health and Human Services

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

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CINCINNATI SUB-ZERO, LLC. HEMOTHERM 400CE CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER. Back to Search Results
Model Number 86022
Device Problem Electronic Property Issue (2928)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2016
Event Type  Malfunction  
Manufacturer Narrative

Cincinnati sub-zero received a complaint stating a fuse blew during a procedure causing the device to malfunction. The technician found the pump malfunctioning due to a blown fuse. Per the csz service manual, the hemotherm must be serviced and/or preventive maintenance must be performed at specific intervals as outlined in the manual. Improper repair and inadequate maintenance can result in damage to the hemotherm system and patient injury. It is unknown if the facility performs preventative maintenance on their devices. Csz has received device and shipped a replacement to the account. The technician replaced the fuse to resolve the issue. Based on this information, no further action is required.

 
Event Description

Cincinnati sub-zero received a report from the account stating the fuse blew on the device during a procedure. The device was located at the account. There was no patient/user injury reported. This report was filed in our complaint handling system as (b)(4).

 
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Brand NameHEMOTHERM 400CE
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
5133265295
MDR Report Key6361413
MDR Text Key68762597
Report Number1516825-2017-00003
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
Type of Report Initial
Report Date 02/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/27/2017
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? Device Returned To Manufacturer
Date Returned to Manufacturer12/01/2017
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/15/2016
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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