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

Model Number 400CE

Device Problem Insufficient Heating (1287)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

Gentherm received a complaint ((b)(4)) stating the device could not reach the desired temperature.The device was switched out and the procedure was completed successfully.No patient harm or injury occurred.Gentherm evaluated the device and found the high amp heater was defective.(b)(4).

Event Description

Customer reported the device did not reach desired temperature.

Manufacturer Narrative

Device returned for evaluation.Service evaluation confirmed the heater was defective.The heater was replaced to correct.

• Brand Name: HEMOTHERM 400CE
• Type of Device: CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati OH 45241
• Manufacturer Contact: christina miracle ; 12011 mosteller; cincinnati, OH 45241 ; 8009897373
• MDR Report Key: 8593288
• MDR Text Key: 150887551
• Report Number: 1516825-2019-00004
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2016
• 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