MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM 400CE HEATER-COOLER

Model Number 400CE

Device Problem Leak/Splash (1354)

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

Event Date 03/06/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4) received.There were no allegations of patient harm and no known patient effect.

Event Description

The customer claims that when selecting cold water pumping, the hot water container ran out of volume and the cold water side filled and overflowed, causing water pooling in the operating room.

• Brand Name: HEMOTHERM 400CE HEATER-COOLER
• Type of Device: HEMOTHERM
• 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
• MDR Report Key: 17699241
• MDR Text Key: 322845374
• Report Number: 1516825-2023-00005
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 1061303186022
• UDI-Public: (01)1061303186022
• Combination Product (y/n): Y
• Reporter Country Code: MX
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• 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
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2018
• 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