MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED SPINNING SPIROS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	UNKNOWN
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date in december of 2024 involving an unspecified spinning spiros.The customer reported that, ¿taxol chemotherapy was hung on the primary intravenous (iv) set with a spinning spiros connection from the secondary tubing placed and made in the pharmacy.After the pump started at a rate of approximately 200 milliliters per hour the registered nurse (rn) walked away but after a few minutes came back to an alarming pump.The taxol was leaking from the spinning spiros connection.The secondary tubing was clamped and the pumped stopped.The spill of approximately 20 milliliters was cleaned per chemotherapy spill protocol by the charge rn.Medication did not touch patient or rn during leakage.The defective device was replaced and therapy resumed.No hole, cut, tears, loose connections, or any defects noted.The device has been discarded due to chemo contamination.The customer stated that "chemo set up (tubing and spiros) delivered from pharmacy- per pharmacy- they use the ref# cl 3011 30¿ 20 drop approx admin set w/ integrated chemolock drop chamber, sprios w/ red cap hanger.There was patient involvement but no adverse events.
Additional Manufacturer Narrative
The device has been discarded.The investigation is pending.
Additional Manufacturer Narrative
The complaint could not be confirmed by investigation.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 a cause cannot be determined.Lot history review could not be reviewed due to the unknown lot number.

• Brand Name: UNSPECIFIED SPINNING SPIROS
• 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: 21433799
• Report Number: 9617594-2025-00329
• Device Sequence Number: 4528590
• Product Code: ONB
• UDI-Device Identifier: 00840619033903
• UDI-Public: 00840619033903
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ICU MED LIST #CL 3011 (30¿ 20 DROP APPROX ADMIN); TAXOL, MFR UNK; UNSPECIFIED PUMP, MFR UNK
• Patient Sex: Unknown