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

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).

• Brand Name: ECMO-HEATER 333W
• Type of Device: CONTROLLER, 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 Key: 6349913
• MDR Text Key: 68037217
• Report Number: 1516825-2017-00002
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 86135
• Device Catalogue Number: 333W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 6 DA
• Patient Weight: 3