MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 3.6 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK¿ AD; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL4131
Medical Device Problem Codes	Fluid/Blood Leak (1250); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a 30" (76 cm) appx 3.6 ml, admin set w/20 drop in-line drip chamber, chemolock¿ additive port, spiros¿ w/red cap.A medsun mandatory medwatch report (uf/importer report# (b)(4) was received on 16-apr-2025 that stated: "rn hung keytruda and pushed start on plum pump.Fluid started leaking from spinning spiros on keytruda secondary line that came from the pharmacy.Rn closed the clamps on the secondary line and bag was returned to the pharmacy, [redacted], pharmacist aware.Primary tubing changed as highly likely it will alarm proximal occlusion.Pharmacy returned keytruda bag with new secondary tubing.Keytruda did not need to be wasted." there was no report of any human harm.
Additional Manufacturer Narrative
Additional/updated information can be found in b3 - date of event, b5, d10 concomitant products and h6 medical device problem codes.Completion of the complaint investigation remains pending.
Event or Problem Description
Additional information from the customer was received on 05-may-2025 primary tubing set 14687-28 lot number 14204889 cl3011 lot 14170139.The chemotherapy drug is taxotere.No drug was wasted.The b port began leaking as soon as they pressed 'start' on pump after the secondary tubing was attached.Then the pump was turned off and the primary tubing set was changed out cl3011 to resolve issues.There was a likely proximal occlusion.The event occurred on (b)(6) 2025 during use on patient.There was patient involvement and no patient harm.

• Brand Name: 30" (76 CM) APPX 3.6 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK¿ AD
• 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: 22020892
• Report Number: 9617594-2025-00992
• Device Sequence Number: 15828692
• Product Code: ONB
• UDI-Device Identifier: 00887709095779
• UDI-Public: (01)00887709095779(17)291001(10)14189317
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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: CL4131
• Device Lot Number: 14189317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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: 30"DROPADMINSET, CL3011 LOT 14170139, MFR ICU MED.; KEYTRUDA, MFR UNK.; PRIMARY TUBE SET 14687-28 LOT#14204889 MFR ICU MED.; TAXOTERE, MFR UNK.; UNSPECIFIED PLUM INFUSION PUMP, MFR ICU MEDICAL.; UNSPECIFIED PRIMARY IV LINE, MFR UNK.
• Patient Sex: Unknown