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 Flow or Under Infusion (2182)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/30/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the emergency room staff reported a staff reported a patient death associated with a suspected device malfunction, where the device would not infuse faster than 10 minutes.The staff does not believe the death was due to the slow infusion of blood, but they believed the device malfunctioned in that it was not infusing rapidly as they expect to infuse a unit of blood in 1 to 3 minutes.The complaint could not be confirmed because the device was not returned, and there was insufficient objective information (photos/logs/history) to determine probable cause or failure mode.Medical causality / relatedness assessment patient outcome severity: death.Causal relationship to device performance: indeterminate based on currently available information.Rationale: 1.The only clinical linkage provided is a temporal association and an allegation of slower than expected infusion; the reporter also stated staff did not believe the slow infusion caused the death.2.The absence of device return, and objective device data (logs/alarms/service history/photographs) prevents confirmation of malfunction, identification of failure mode, or assessment of whether device performance deviated from specification versus external factors.3.The absence of patient level clinical details prevents evaluation of biological plausibility and dose /time response (i.E., whether transfusion delay could reasonably have contributed to the death in this specific case).
Additional Manufacturer Narrative
The complaint could not be confirmed because the device was not returned, and there was insufficient objective information (photos/logs/history) to determine probable cause or failure mode.Medical causality / relatedness assessment patient outcome severity: death.Causal relationship to device performance: indeterminate based on currently available information.Rationale: 1.The only clinical linkage provided is a temporal association and an allegation of slower than expected infusion; the reporter also stated staff did not believe the slow infusion caused the death.2.The absence of device return, and objective device data (logs/alarms/service history/photographs) prevents confirmation of malfunction, identification of failure mode, or assessment of whether device performance deviated from specification versus external factors.3.The absence of patient level clinical details prevents evaluation of biological plausibility and dose /time response (i.E., whether transfusion delay could reasonably have contributed to the death in this specific case).

• 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 aleman km 21; parque industrial monterrey; apodaca nl CP666 03; MX CP66603
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25004759
• Report Number: 3012307300-2026-04236
• Device Sequence Number: 9813967
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: (01)50695085829506(11)141204
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: BK020043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: 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: 03/31/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2015
• 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