MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, LLC/GENTHERM MEDICAL, LLC HEMOTHERM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Device Problem Failure of Device to Self-Test (2937)

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

Event Date 07/15/2022

Event Type  malfunction  

Event Description

When heater/cooler was turned on for checks in the morning it triggered a circuit alarm.Unit was turned off and another attempt was made.Alarm resumed.Unit was exchanged with another, pulled for service, and biomed notified.This all occurred prior to patient being in the operating room.Fda safety report # (b)(4).

• Brand Name: HEMOTHERM
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CINCINNATI SUB-ZERO PRODUCTS, LLC/GENTHERM MEDICAL, LLC
• MDR Report Key: 15121570
• MDR Text Key: 296857512
• Report Number: MW5111157
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/26/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2022
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male