MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V LEVEL 1 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Catalog Number	8002950
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
B2: date of death: the date of death is unknown, and the event date has been used.H3: 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 infuser failed to heat the blood being infused, resulting in a delay in therapy while a second unit was set up.The staff continued to infuse the blood, due to massive blood transfusion needed.This was during a code situation they gained rosc on the patient.Later the patient was transitioned to comfort care and passed away.This event occurred during infusion.Based on the currently available complaint narrative, a patient death occurred in the setting of a code event with reported massive blood transfusion, where it was alleged that the level 1® fast flow fluid warmer failed to heat blood during infusion, resulting in a delay in therapy while a second unit was set up; rosc was reportedly achieved, the patient was later transitioned to comfort care, and subsequently died.The patient¿s medical history and key clinical context are not provided, including the underlying diagnosis and clinical circumstances that precipitated the code event, the indication for and magnitude of the massive transfusion requirement, objective temperature data (patient core temperature and/or device outlet temperature), transfusion volumes and rates, the duration of any period of reduced/absent warming, and the clinical rationale for the subsequent transition to comfort care.In the absence of these details, a plausible device related mechanism linking the alleged warming failure/delay to the patient¿s outcome cannot be established from the information currently available.Notably, the customer response indicated the delay did not contribute to patient harm.Therefore, a causal relationship between the device and the reported death cannot be confirmed or excluded at this time, and the clinical causality assessment is indeterminate pending investigation and receipt of additional clinical information and objective device evaluation results.Should further relevant data become available, this medical assessment may be updated.The date of death is unknown, and the event date has been used.
Additional Manufacturer Narrative
D9 - date returned to mfr was 29-may-2026.G4 - updated h3 and h6 ¿ updated one suspected device was received for evaluation.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.The in-house service history for the last 24 months revealed the device was remediated at the depot for the return tube and membrane switch on slc service depot.Post remediation the device had passed all performance verification tests.Visual inspection revealed device arrived in good condition.During testing the customer complaint was unable to be replicated.No repairs needed at the time of this investigation.Device passed all performance verification tests.

• Brand Name: LEVEL 1 FAST FLOW FLUID WARMER
• Common Device Name: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; carretera miguel alemán km21.7; apodaca nuevo leon CP666 03; MX CP66603
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25246136
• Report Number: 3012307300-2026-05283
• Device Sequence Number: 16088962
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: (01)50695085829506(11)151014
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: BK020043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown