MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER, 230 V CONTINENTAL EUROPE; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problem Overheating of Device (1437)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is unknown, no information has been provided to date.Device evaluation: one device was returned for investigation.Visual inspection found the unit looks in used condition.No cracks or leaks were visible.Functional testing could not duplicate or confirm the complaint.The device heats the circulation solution to 42.0 degrees and remains stable.Unit runs for more than 2 hours with no temperature variations detected.Checked all alarm settings, no problem found.Preventive maintenance performed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

Event Description

It was reported that the temperature was greater than 90 degrees.Patient involvement is unknown.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER, 230 V CONTINENTAL EUROPE
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18511103
• MDR Text Key: 333354681
• Report Number: 2183161-2024-00045
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: (01)50695085820909(11)090617
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HL-90
• Device Catalogue Number: HL-90-INT-230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1