MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 LOW FLOW HOTLINE DISPOSABLE SET; WARMER, THERMAL, INFUSION FLUID

Catalog Number	L-370
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hotline 3 recirculating fluid went into the patient side of the tubing.The device was broken off and went to the patient.There was no external leaking.There was patient involvement, and there was no reported harm.
Additional Manufacturer Narrative
B3: date of event is unknown.The primary di# has been used as the lot information is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H3 and h6 codes - updated.One used device was returned for investigation.The device was visually inspected and found no damage or anomalies were observed.During the functional testing, the breach was identified on the lower half of the tubing.The complaint of recirculating fluid path going into the patient side can be confirmed.The probable cause is due to an extrusion error during manufacturing.A device history record (dhr) review could not be performed as the lot number was unknown.

• Brand Name: LEVEL 1 LOW FLOW HOTLINE DISPOSABLE SET
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24250309
• Report Number: 3012307300-2026-00848
• Device Sequence Number: 18556257
• Product Code: LGZ
• UDI-Device Identifier: 10695085002819
• UDI-Public: (01)10695085002819
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: Other
• Device Catalogue Number: L-370
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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