MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3011
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received two (2) used ch3011 admin sets w/ integrated chemo clave for inspection.Each chemoclave was stuck down as received.Each chemoclave was disassembled, and the internal spikes were found to be bent and broken.The reported complaint of no flow can be confirmed due to the stuck-down and damaged chemoclaves.The probable cause is due to a salt lake city molding defect.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
It was reported, on an unknown date, that a 30" (76 cm) appx 3.3 ml, 20 drop admin set w/integrated chemoclave® drip chamber, spiros® w/red cap, bag hanger was found to be occluded during patient use.It was stated in the report that the drug was pulled into a syringe from a vial with spiros (ch2000sc-10), then connected to the ch3011 circle priming port for infusion into the bag.The fluid path would not allow any infusion from the syringe + spiros into the bag.When the syringe + spiros was detached, their circle priming clave did not have ¿stick down¿.The pharm tech removed the spiros and tested if they could infuse using only a syringe, and it worked.This issue was very consistent, at least one, if not multiple times a day.There was no patient harm reported.

• Brand Name: 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBE
• 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: 22560459
• Report Number: 9617594-2025-01507
• Device Sequence Number: 9700532
• Product Code: ONB
• UDI-Device Identifier: 00840619023966
• UDI-Public: (01)00840619023966(17)300401(10)14372311
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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: CH3011
• Device Lot Number: 14372311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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