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

Catalog Number	8002950
Medical Device Problem Codes	No Audible Alarm (1019); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.H3: 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.
Event or Problem Description
It was reported that the unit overheated and did not alarm.There was no led illumination or audible over-temperature alarm, even when the unit¿s temperature reached 46 °c.However, the test alarm functioned correctly¿during testing, both the led and audible alarm activated as expected.The event occurred during use.The unit was not dropped.There was no delay of therapy.There was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
H3: one device was returned for analysis in used condition.Visual inspection showed the pump was in good condition.Service history identified the complaint was not related to a previous service of the device within the review period.It was found during functional testing that the unit was overheated during use, and the over-temperature alarm was not triggered.No patient harm or therapy delay occurred.Diagnostics confirmed the top thermistor was not sending a signal, and the mainboard was damaged due to fluid ingress.Both the top thermistor and mainboard were replaced to address this issue.

• Brand Name: LEVEL 1 FAST FLOW FLUID WARMER
• Common Device Name: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel aleman km; apodaca nl CP666 03; MX CP66603
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22932537
• Report Number: 3012307300-2025-10160
• Device Sequence Number: 10231001
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: (01)50695085829506(11)160830
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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: 8002950
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown