MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5.5" (14 CM) APPX 0.37 ML, SMALLBORE BIFUSE EXT SET W/2 CHEMOCLAVE®, SPIROS® W/R; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3699
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to be returned for evaluation; however, device history is pending.
Event or Problem Description
The event involved a 5.5" (14 cm) appx 0.37 ml, smallbore bifuse ext set w/2 chemoclave®, spiros® w/red cap, 2 clamps where it was reported that the patient was admitted for chemo; typical set up with hazardous medline, hazardous syringe, and mivf line with a trifuse spiros at the end.Prepared line by resource rn.Spiros clicked into place and able to swivel with a c-clamp on.Patient had already infused fluid boluses and then took a walk in the hallway.In the hallway blood started to back up into patient line and leak out of the hazardous medline at the site of the spiros while patient was riding a toy car.Patient stopped and line was disconnected from trifuse and hazardous medline was saved to give to management.There was patient involvement and no injury.
Additional Manufacturer Narrative
No product samples, videos, or photographs were returned for investigation.The dhr was reviewed and there were no non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: 5.5" (14 CM) APPX 0.37 ML, SMALLBORE BIFUSE EXT SET W/2 CHEMOCLAVE®, SPIROS® W/R
• 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: 19934011
• Report Number: 9617594-2024-01093
• Device Sequence Number: 8234198
• Product Code: FPA
• UDI-Device Identifier: 00887709089174
• UDI-Public: 00887709089174
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 10/04/2024

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: CH3699
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/05/2024
• 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: HAZARDOUS MEDLINE, MFR UNK.; MIVF LINE.; SYRINGE, MFR UNK.; TRIFUSE SPIROS, MFR UNK.
• Patient Sex: Unknown