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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CINCINNATI SUB-ZERO, LLC. ECMO-HEATER 333W CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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CINCINNATI SUB-ZERO, LLC. ECMO-HEATER 333W CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 86135
Device Problem Device Stops Intermittently (1599)
Patient Problems Complaint, Ill-Defined (2331); Injury (2348)
Event Date 12/07/2016
Event Type  Injury  
Manufacturer Narrative
Patient with hypoxic ischemic encephalopathy vs. Meconium aspiration syndrome on extracorporeal membrane oxygenation (ecmo device) for the third day. The patient's temperature dropped and began hemorrhaging. The accounts staff did not recognize the change in the baby's temperature since they were not monitoring continuously. The patient coded. The outcome is the patient did survive. The account alleged that the ecmo device water circulation stopped working causing the baby's temperature to drop. The device was removed from service and tested by the facility's biomed department. 4 tests below were performed by facility's biomed and documented. Functional test confirmed unit hits target temperature - pass. Functional test confirmed unit circulates fluid- pass. Functional test confirmed unit resumes function after power interruption - pass. Functional test confirmed unit temp set point defaults to 37 when power is interrupted - pass. The accounts tests confirmed that the problem alleged could not be replicated. Per the csz operation & technical manual pg 47, 3 potential causes could have stopped the circulation of water. Shut-off valves on the connecting hose(s) are in the off position. Clogged water line. Pump not running. Per accounts testing these potential causes of water circulation disruption did not occur. The ecmo device used is past it useful life and it is unknown if the facility performs preventative maintenance on their devices. Csz has made multiple attempts to have the device returned for further evaluation. The investigation and testing confirms the device functioned as designed. If any new additional relevant information is identified, the complaint will be revaluated and characterized accordingly. Based on this information, no further action is required. Multiple attempts made for device rma.
 
Event Description
Csz received a medwatch concerning an allegation that an ecmo device water stopped circulating during treatment. The device was located at the account. There was an allegation of patient involvement. The female patient coded and did survive from this alleged incident. This report was filed in our complaint handling system as complaint (b)(4).
 
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Brand NameECMO-HEATER 333W
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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 Key6349913
MDR Text Key68037217
Report Number1516825-2017-00002
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number86135
Device Catalogue Number333W
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/15/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/22/2017 Patient Sequence Number: 1
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