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

Catalog Number	CL4146-5
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Event or Problem Description
The event involved a 30" (76 cm) 20 drop admin set w/integrated chemolock¿ port drip chamber, chemolock¿; 5 units where the customer reported a leak was where the tubing bonds to the chemolock cl2000s.The patient reported seeing dripping towards the end of the infusion, the nurse reported it to the pharmacy and she saw it as well and cleaned the area according to their spill policy.A spill kit was used.The estimated amount of spill was 3ml of irinotecan 25021-230-05, dose was 330 mg.The staff or patient did not require medical attention.There was patient involvement but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device was received for evaluation 6/6/2024.One (1) used unit.List #cl4146-5, 30" (76 cm) 20 drop admin set w/integrated chemolock¿ port drip chamber, chemolock¿; 1 unit; lot #unknown.One (1) used.List #unknown, icu medical 0.9% sodium chloride injection, usp 500 ml intravenous bag with irinotecan; lot #1015219.Confirmed customer complaint of leaking.Probable cause luer connection not fully engaged before solvent bond.Also received five (5) new.List #cl4146-5, 30" (76 cm) 20 drop admin set w/integrated chemolock¿ port drip chamber, chemolock¿; 5 units; lot #13527640.All 5 were tested and meet manufacture specifications.The lot history of the provided new devices was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 30" (76 CM) 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHAMBER, CHEMOLO
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19484557
• Report Number: 9617594-2024-00741
• Device Sequence Number: 8030350
• Product Code: ONB
• UDI-Device Identifier: 00887709097469
• UDI-Public: 00887709097469
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: CL4146-5
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: CL2000S, MFR UNK.; IRINOTECAN 25021-230-05 330MG, MFR UNK.
• Patient Sex: Unknown