MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 FLUID WARMER IV SET; DEVICE, WARMING. BLOOD AND PLASMA

Catalog Number	DI-100
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	06/01/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the patient was in cardiac arrest from a dissection.They were attempting to give multiple units of blood through the level 1 infuser, but the tubing kept kinking and this caused decreased flow and prolonged time to give blood to the patient.They had to supplement the level 1 infuser with giving blood through a pressure bag until they could get the tubing unkinked.They were unable to puncture blood bag with level 1 infuser tubing in a critical situation with a patient.It took several tries by multiple people to puncture the blood bag with the tubing.The patient ultimately did not survive.There was patient involvement, and patient death was reported while using icu product.The device and patient death were not related.Medical evaluation: based on the available information, there is no objective evidence confirming a device malfunction, as no device or lot was available for evaluation.Additionally, alternative transfusion methods were successfully employed to continue therapy.While the reported device performance issues may have contributed to procedural delays, the primary cause of death is most consistent with the underlying medical condition.In summary, the relationship between the device and the patient outcome is assessed as not established, though a contributory role cannot be excluded due to the reported flow limitation and access difficulties during a time-critical resuscitation.

• Brand Name: LEVEL 1 FLUID WARMER IV SET
• Common Device Name: DEVICE, WARMING. BLOOD AND PLASMA
• 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: 25782353
• Report Number: 3012307300-2026-07331
• Device Sequence Number: 10686550
• Product Code: KZL
• UDI-Device Identifier: 20695085410017
• UDI-Public: (01)20695085410017
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 07/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DI-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown