MAUDE Adverse Event Report: CARDIOQUIP, LLC HEATER COOLER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Device Problem Device Alarm System (1012)

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

Event Date 01/31/2022

Event Type  malfunction  

Event Description

Informed by perfusion that the heater/cooler was alarming.Device removed from use and biomed called for service on equipment.

• Brand Name: HEATER COOLER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP, LLC; 8422 calibration ct; college station TX 77845
• MDR Report Key: 14458052
• MDR Text Key: 295251319
• Report Number: 14458052
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/03/2022

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6935 DA
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Race: White