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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
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) appx 3.6 ml, admin set w/20 drop in-line drip chamber, chemolock¿ additive port, spiros¿ w/red cap where the customer reported that the hazardous drug leaked from the tubing during patient use.The customer stated that the nurse hung the chemo (carfilzomib) after dual sign off with second nurse.While the nurse was still at the chairside, they noted fluid leaking from the spinning spiros on the secondary tubing that came from the pharmacy (that was connected to the clave on the primary tubing).The secondary/chemo line was primed with saline, so first few drops that leaked out would have been saline.The nurse closed all clamps and turned off the plum pump.Bag and tubing were returned to the pharmacy.Pharmacy put new secondary tubing on the carfilzomib, did not have to waste the bag.Upon hanging the new bag, the plum pump alarmed "proximal occlusion".The nurse stopped the pump and noticed that the clave appeared to be "pushed in".The nurse changed out primary tubing line.There was patient involvement however, harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The complaint of leaks on item cl4131 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.Lot history review was conducted and no non-conformities were found that would have led to the reported condition on the complaint.
Additional Manufacturer Narrative
Additional information in h6- investigation conclusions.

• 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: 21972536
• Report Number: 9617594-2025-00920
• Device Sequence Number: 8260655
• Product Code: ONB
• UDI-Device Identifier: 00887709095779
• UDI-Public: (01)00887709095779(17)290801(10)14114404
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2025

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: 14114404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 09/15/2025; 09/15/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 10/09/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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: CARFILZOMIB, MFR UNK.; MICROCLAVE, ICU MEDICAL, PRODUCT INFORMATION UNK.; SPINNING SPIROS, ICU, PRODUCT INFO UNK.
• Patient Sex: Unknown