MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHA; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3528
Medical Device Problem Codes	Separation Problem (4043); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
Event occurred regarding a 30" (76cm) appx 6.3 ml, 20 drop admin set w/integrated chemolock¿ port drip chamber, 0.2 micron filter, chemolock¿ w/red cap, hanger where the reporter stated that "an iv pump was running patient¿s chemo, and epoch (doxorubicin, etoposide, & vincristine) was beeping with "air in line" message.Csl went into room to check and found air bubble in secondary tubing past the filter.Csl connected the blue chemo port locks together in order to cycle out the air bubble.When csl reached up to disconnect the chemo port locks on the secondary iv tubing, the entire secondary tubing set fell out of the chemo bag where it was spiked." the 3/4 full bag of epoch was drained from bag hanging on top of iv pole.They also reported earlier event where iv pump showed "air in line" error multiple times requiring frequent untwisting and opening iv pump lever in order to resolve air bubble.There was patient involvement, no patient harm and unknown delay in critical therapy reported.
Additional Manufacturer Narrative
A photo was returned showing a part of the filter of the cl3528.No defects or anomalies noted.The reported complaint could not be confirmed.Without the return of the used sample a comprehensive failure investigation cannot be performed.The device history review (dhr) was reviewed and no nonconformities were found that would have led to the reported complaint.

• Brand Name: 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHA
• 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: 22883553
• Report Number: 9617594-2025-01734
• Device Sequence Number: 13171917
• Product Code: ONB
• UDI-Device Identifier: 00887709057043
• UDI-Public: (01)00887709057043(17)290801(10)14120421
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: CL3528
• Device Lot Number: 14120421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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: DOXORUBICIN, MFR UNKNOWN; ETOPOSIDE - MFR UNKNOWN; VINCRISTINE, MFR UNKNOWN
• Patient Sex: Unknown