MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 M; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	425900405
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a transpac¿ iv trifurcated monitoring kit 60 inch, 3 disposable transducers, 3 3 ml squeeze flush, macrodrip (pole mount) where it was reported teh clinician observed blood had started to back flow into the pulmonary artery (pa) line and began to leak from a crack/hole on the distal stopcock.There was patient involvement and no adverse event/patient harm.
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned; however, it has not been received.Without the returned device, a probable cause is unable to be determined.
Additional Manufacturer Narrative
D9 - date returned to mfg: 6 may 2025 investigation summary, the reported complaint of leak was confirmed on the returned set.During visual inspection, a crack was observed on the female luer which is connected to the 48" pressure tubing.When the returned partial set was primed and pressure leak tested, a leak was observed from the crack.The probable cause of the leak is unknown the lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC® IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 M
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 22070602
• Report Number: 9617594-2025-01084
• Device Sequence Number: 8398134
• Product Code: DRS
• UDI-Device Identifier: 00840619063184
• UDI-Public: (01)00840619063184(17)270501(10)13998561
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K061573
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 425900405
• Device Lot Number: 13998561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 06/14/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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
• Patient Sex: Unknown