MAUDE Adverse Event Report: ICU MEDICAL MANUFACTURING S.A. DE C.V. NRFIT ADMINISTRATION SET; SET, I.V. FLUID TRANSFER

Catalog Number	21-7624-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 information becomes available.
Event or Problem Description
It was reported that the device alarmed with a red screen and air in the tubing was observed at the time of the alarm.Per reporter, it was then noticed that the bag was damp, and reporter clarified the air in the tubbing was from the pump and down a bit, but not into the patient.The bag was replaced but the issue recurred.Reporter stated the unit was replaced and it was then noticed there was a hole in the tubing, right next to the connector that attaches to the pump.There was patient involvement, but no patient harm was reported.
Additional Manufacturer Narrative
H3: two samples were received for evaluation.As received tears were observed on the housing tubing.The cut on sample one was on the top side of the tubing, the lining was observed to be clean.The tear on sample 2 was on the side of the tubing at the base of the housing solvent.The lining was observed to be clean at the center.The customer complaint was confirmed.The root cause of the issue was unknown.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: NRFIT ADMINISTRATION SET
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): ICU MEDICAL MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23457459
• Report Number: 3012307300-2025-12006
• Device Sequence Number: 9040560
• Product Code: LHI
• UDI-Device Identifier: 10610586044748
• UDI-Public: (01)10610586044748(17)270612(10)6108349
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K162219
• Number of Events Summarized: 1
• 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,Followup
• Report Date (Section B): 11/26/2025

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: 21-7624-24
• Device Lot Number: 6108349
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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