MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, INC. HEMOTHERM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 400CE

Device Problems Device Displays Incorrect Message (2591); No Flow (2991); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 02/23/2020

Event Type  malfunction  

Event Description

While on cpb, heater cooler alarmed and stopped functioning.The right hand side of heater cooler (heat side) showed ee, instead of temperature and water was not flowing.I attempted a reboot resulting in the same error message.Water lines were quickly changed to a different to heater cooler.

• Brand Name: HEMOTHERM
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CINCINNATI SUB-ZERO PRODUCTS, INC.; 12011 mosteller rd 3rd floor; blue ash OH 45241
• MDR Report Key: 10013226
• MDR Text Key: 189454198
• Report Number: 10013226
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2020

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: No Information
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5840 DA