MAUDE Adverse Event Report: ICU MEDICAL, INC LEVEL 1 HIGH FLOW WARMER; DEVICE, WARMING. BLOOD AND PLASMA

Catalog Number	DI-60HL
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that with the device the part where the gas-vent filter and the blood transfusion route (a tubing) were connected was leaking.There was patient involvement, and no patient harm 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 summary: there were photographs for review.The customer provided these photos above for evaluation.In the image it showed a di-60 set.It¿s not possible to see the failure mode ¿leaking¿ reported in the complaint.According to the visual inspection the failure mode reported in the complaint was not confirmed.No root cause established.A device history record could not be completed as no lot number was received.
Additional Manufacturer Narrative
D3: mfg establishment name; icu medical, inc.Device evaluation: one used device was received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.Functional testing and visual inspection performed during analysis.The customer reported complaint was confirmed and device was found leaking.The leak is due to insufficient solvent coverage error during assembly.

• Brand Name: LEVEL 1 HIGH FLOW WARMER
• Common Device Name: DEVICE, WARMING. BLOOD AND PLASMA
• Manufacturer (Section D): ICU MEDICAL, INC; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20033058
• Report Number: 9617604-2024-00672
• Device Sequence Number: 6423797
• Product Code: KZL
• UDI-Device Identifier: 20695085406010
• UDI-Public: (01)20695085406010
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: BK860023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2025

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: DI-60HL
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 09/06/2024; 09/23/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/01/2024; 10/02/2025
• 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