MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, INC. BLANKETROL LLL; SYSTEM, THERMAL REGULATING

Model Number 233

Device Problem Defective Device (2588)

Patient Problem Alteration in Body Temperature (4568)

Event Date 04/22/2021

Event Type  malfunction  

Event Description

Called to bedside because patient was not reaching goal temp of 33.5°c and the water indicator wheel, from the blanketrol iii system, was no longer spinning.Health care providers checked the machine to make sure there were no kinks in the hoses or blanket that would cut off the flow.Went through all trouble shooting steps and then switched out the machine.The second machine then read "snap disc", and we had to go to the pediatric intensive care unit to find a third machine.But, encountered the same issue with the third machine.Cincinnati sub-zero products, inc.24hr support line was contacted, and while waiting for additional help, decided to grab a different blanket (which was a different lot #).It was later discovered that the issue was with the blanket itself, and the water not flowing through the blankets.After all the troubleshooting and switching of machines and blankets, the infant patient did not reach the goal temperature, that is typically achieved within 1 hour of arrival, until almost 6 hours later.

• Brand Name: BLANKETROL LLL
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): CINCINNATI SUB-ZERO PRODUCTS, INC.; 12011 mosteller rd 3rd floor; blue ash OH 45241
• MDR Report Key: 11811839
• MDR Text Key: 250241284
• Report Number: 11811839
• Device Sequence Number: 1
• Product Code: DWJ
• 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: 04/30/2021

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: Other
• Device Model Number: 233
• Device Catalogue Number: 86107
• Device Lot Number: 18588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1