MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15" (38 CM) APPX 5.2 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS¿, 3 CLAMPS (BLUE,; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3187
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following device: 15" (38 cm) appx 5.2 ml, bifuse add-on set w/bag spike, spiros¿, 3 clamps (blue, red, white), dry spike adapter reportedly leaked at the spiro during a patient's (second) cisplatin infusion.It was stated in the report that paclitaxel infusion was ok initially before the leak during the second infusion.There was no bleed back reported.There was no patient harm nor any delay in critical therapy.
Additional Manufacturer Narrative
Although multiple attempts were made to obtain the device, it is not available for investigation at this time.The complaint investigation is still pending.
Additional Manufacturer Narrative
Received one used ch3187 bifuse add-on set connected to one used ch-14 and various mating devices.No defects or anomalies on initial inspection.The ch3187, ch-14, and mating devices were leak tested per product specifications.There was leakage from the spiros connection to the ch-14.The ch-14 and spiros from the ch3187 were disconnected and a stick down was found on the chemoclave of the ch-14.The ch3187 was leak tested again without the ch-14.There was no leakage.The complaint of leakage could not be confirmed on the ch3187.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 date returned to mfg: 10/27/2025.Additional reporter information: (b)(6).Corrected information can be found in e1.

• Brand Name: 15" (38 CM) APPX 5.2 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS¿, 3 CLAMPS (BLUE,
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 23363302
• Report Number: 9617594-2025-02025
• Device Sequence Number: 8863934
• Product Code: ONB
• UDI-Device Identifier: 00840619025335
• UDI-Public: (01)00840619025335(17)290601(10)14045176
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K173477
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: CH3187
• Device Lot Number: 14045176
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CISPLATIN, MFR UNK
• Patient Sex: Unknown