MAUDE Adverse Event Report: SMITHS MEDICAL LEVEL 1 HOTLINE FLUID WARMER; SYSTEM, THERMAL REGULATING

Catalog Number	CON-HL-90
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was not regulating temperature correctly.The whole system needed to be checked ensure it was functioning and no leaks.There was no patient involvement and no adverse effects reported.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Investigation codes: updated.Investigation summary: the affected device was returned for evaluation.Visual inspection found cracked case assembly, damaged ac cable, and degraded main board and heater assembly.The customer's indicated failure was confirmed.The root cause was the cracked/leaking case assembly at the drain tube.The case assembly was replaced to resolve the reported error.The ac cable, main board kit with switch, and heater assembly were also replaced.The device passed all functional tests after the repair.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19697316
• Report Number: 3012307300-2024-05861
• Device Sequence Number: 8130833
• Product Code: DWJ
• UDI-Device Identifier: 15019517121551
• UDI-Public: (01)15019517121551(11)090609
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K001764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown