MAUDE Adverse Event Report: 3M COMPANY 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET; WARMER, BLOOD, NONELECTROMAGNETIC RADIATION

Model Number	24355
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.At this time, the product has not yet been returned for this complaint.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the libre sensor and sensor kit was reviewed and the dhrs showed the libre sensor and sensor kit met specifications prior to release to distribution.If the product is returned, a physical investigation will be performed and a follow-up report will be submitted.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A user facility reported three 3m¿ ranger¿ blood/fluid warming high flow sets leaked while using a rapid infuser.There was a code transfusion in the intensive care unit and two different sets of tubing separated at the spike and tube connection, resulting in two staff members getting blood on their face.This also occurred during a code transfusion in the emergency department earlier in the week, resulting in exposure to a staff member.No injuries or medical interventions were indicated due to the alleged malfunctions.
Additional Manufacturer Narrative
Unused sets from the same lot were received for analysis.The reported issue was not confirmed, all samples passed specifications.The root cause of the alleged malfunction could not be determined.Possible causes include pulling on tubing instead of holding on to the spike, excessive twisting of spike, excessive force on tubing when removing spike from infusion bag, or over pressurization of set above 300 mmhg.A review of the batch record showed this lot met all specification for product release and no deviations were found that could have caused or contributed to the reported malfunction.Solventum will continue to monitor.

• Brand Name: 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET
• Common Device Name: WARMER, BLOOD, NONELECTROMAGNETIC RADIATION
• Manufacturer (Section D): 3M COMPANY; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): NPA DE MEXICO S. DE R.L. DE C.V.; sor juana ines de la cruz #201; 50 interior 5, cd. industrial; tijuana,baja california
• Manufacturer Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; 2103743188
• MDR Report Key: 23075240
• Report Number: 2110898-2025-00060
• Device Sequence Number: 15891758
• Product Code: BSB
• UDI-Device Identifier: 10707387792685
• UDI-Public: 0110707387792685112502251728022510HX9911
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K973741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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 Model Number: 24355
• Device Catalogue Number: 24355
• Device Lot Number: HX9911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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
• Patient Sex: Unknown