MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. MR. FROSTY; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Patient Problem Alteration in Body Temperature (4568)

Event Date 10/23/2023

Event Type  Injury  

Event Description

Cardiopulmonary bypass heater/cooler device "failure" to reheat patient.Patient temperature 31.8c when device failed.

• Brand Name: MR. FROSTY
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SPECTRUM MEDICAL LTD.
• MDR Report Key: 18086510
• MDR Text Key: 327646605
• Report Number: MW5147868
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/01/2023

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 Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White