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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V LEVEL 1 HOTLINE FLUID WARMER, 230 V ITALIAN MODEL; WARMER, THERMAL, INFUSION FLUID
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ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V LEVEL 1 HOTLINE FLUID WARMER, 230 V ITALIAN MODEL; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Catalog Number HL-90-IT-230
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/01/2026
Type of Reportable Event Malfunction
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Brand Name
LEVEL 1 HOTLINE FLUID WARMER, 230 V ITALIAN MODEL
Common Device Name
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V
carretera miguel aleman km21.7
parque industrial monterrey
apodaca nl 66603
MX  66603
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key25752615
Report Number3012307300-2026-07229
Device Sequence Number16068891
Product Code LGZ
UDI-Device Identifier50695085820909
UDI-Public(01)50695085820909(11)100813
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K911383
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,User Facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
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? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberHL-90-IT-230
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2026
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/23/2026
Initial Report FDA Received Date07/08/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured08/13/2010
Is the Device Labeled for Single Use? (Y/N) No
Usage of Device Reuse
Patient Sequence Number1
Patient SexUnknown
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