MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM 400CE; CARDIOPULMONARY BYPASS TEPERATURE CONTROLLER

Model Number 400CE

Device Problem Unintended Collision (1429)

Patient Problems Cardiopulmonary Arrest (1765); Ventricular Fibrillation (2130)

Event Type  malfunction  

Manufacturer Narrative

Gentherm received a medwatch report (#mw5085957) (complaint (b)(4)), stating a staff member lead against the hemotherm device which inadvertently pressed the cool button causing the device to cool rapidly.

Event Description

Female being supported on ecmo.Staff member leaned against the hemotherm ce heater/cooler machine and hit cool button.No temperature parameters were set so machine cooled very rapidly and patient went into v-fib arrest.She was re-warmed and had rosc.

• Brand Name: HEMOTHERM 400CE
• Type of Device: CARDIOPULMONARY BYPASS TEPERATURE CONTROLLER
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati OH 45241
• Manufacturer (Section G): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati OH 45241
• Manufacturer Contact: christina miracle ; 12011 mosteller; cincinnati, OH 45241 ; 8009897373
• MDR Report Key: 8672848
• MDR Text Key: 150887489
• Report Number: 1516825-2019-00006
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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