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

Model Number 400CE

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

Gentherm received a complaint (cdr # (b)(4)) stating the device went down during a procedure.During the evaluation of the device by the customer, debris was found inside the solenoid.Customer corrected the issue and retested the device.The device functioned properly.No patient harm or injury occurred.

Event Description

Customer states that the hemotherm device went down during a procedure.While the unit was in heat mode, the heat reservoir was filling while the cool side was emptying.

• 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: 8742148
• MDR Text Key: 150886598
• Report Number: 1516825-2019-00008
• 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
• Report Date: 06/25/2019

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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