MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 16" (41 CM) APPX 6.3 ML, TRIFUSE ADD-ON SET W/2 SPIROS¿, BAG SPIKE, 3 CLAMPS (BL; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH3227
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - (b)(6).The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a 16" (41 cm) appx 6.3 ml, trifuse add-on set w/2 spiros®, bag spike, 3 clamps (blue, 2 red), dry spike adapter that experienced air in line.It was stated in the report that ¿air in line.¿ the event occurred on (b)(6) 2025, during infusion.There was concomitant drug used, and concomitant device involved.No bleedback was noted and there was no delay in critical therapy.There were no obvious defects noted on the product.There was patient involvement reported, but no patient harm/adverse event reported.There were 2 samples affected.
Additional Manufacturer Narrative
Received a photo and video from the customer showing the affected sample.The sample gave an air in line error on the pump.The reported complaint of air in line could be confirmed from the received video.However, without the return of the sample a comprehensive review cannot be performed and a probable cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in d9 and g2.

• Brand Name: 16" (41 CM) APPX 6.3 ML, TRIFUSE ADD-ON SET W/2 SPIROS¿, BAG SPIKE, 3 CLAMPS (BL
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21939431
• Report Number: 9617594-2025-00870
• Device Sequence Number: 8691446
• Product Code: FPA
• UDI-Device Identifier: 00840619025687
• UDI-Public: (01)00840619025687(17)290401(10)13992104
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K070532
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: CH3227
• Device Lot Number: 13992104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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