MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM; Controller, temperature, cardiopulmonary bypass

Model Number 400CE

Device Problem Insufficient Heating (1287)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

Complaint #(b)(4) received.There were no allegations of patient harm.The customer did not return the device for evaluation.

Event Description

Customer reports: "we had an issue with one of our hemotherm (b)(4) units (s/n (b)(6), va biomed ee 194-11307ce) yesterday during our case.Upon rewarming the patient/unit, the warm side would not go above 34 degrees.We switched out units to continue rewarming our patient.There was not any alarm on the affected unit.".

• Brand Name: HEMOTHERM
• Type of Device: Controller, temperature, cardiopulmonary bypass
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer (Section G): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer Contact: angie gegner ; 12011 mosteller rd; cincinnati, OH 45241 ; 5133265228
• MDR Report Key: 18090867
• MDR Text Key: 327598168
• Report Number: 1516825-2023-00007
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 1061303186022
• UDI-Public: (01)1061303186022
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2023

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 Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1