MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 HOTLINE FLUID WARMING GAS VENT ACCESSORY; WARMER, THERMAL, INFUSION FLUID

Catalog Number	L-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.E1.Initial reporter last name and email address unknown.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.
Event or Problem Description
It was reported that during priming, the device was leaking from the filter.There was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
One device was returned.Functional and visual testing were performed.During the functional testing it was detected that the distilled water passed through the sample without difficulty, no leaks were detected during the test.The reporter's problem was not confirmed.The root cause is unknown due to no problem found.A device history record could not be completed as no lot number was received.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMING GAS VENT ACCESSORY
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19741718
• Report Number: 3012307300-2024-06119
• Device Sequence Number: 20763314
• Product Code: LGZ
• UDI-Device Identifier: 40695085401002
• UDI-Public: (01)40695085401002
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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: L-10
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown