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	04/22/2025
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 the 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
Received: two (2) new.List #425900405, transpac¿ iv trifurcated monitoring kit 60 inch, 3 disposable transducers, 3 3 ml squeeze flush, macrodrip (pole mount); lot #13946836 two (2) new.List #425900405, transpac¿ iv trifurcated monitoring kit 60 inch, 3 disposable transducers, 3 3 ml squeeze flush, macrodrip (pole mount); lot #13723036 one (1) new.List #425900405, transpac¿ iv trifurcated monitoring kit 60 inch, 3 disposable transducers, 3 3 ml squeeze flush, macrodrip (pole mount); lot #8602121 eight (8) new.List #425900405, transpac¿ iv trifurcated monitoring kit 60 inch, 3 disposable transducers, 3 3 ml squeeze flush, macrodrip (pole mount); lot #14292629 one (1) new.List #425900405, transpac¿ iv trifurcated monitoring kit 60 inch, 3 disposable transducers, 3 3 ml squeeze flush, macrodrip (pole mount); lot #5206361 three (3) new.List #425900405, transpac¿ iv trifurcated monitoring kit 60 inch, 3 disposable transducers, 3 3 ml squeeze flush, macrodrip (pole mount); lot #14228647 two (2) new.List #425900405, transpac¿ iv trifurcated monitoring kit 60 inch, 3 disposable transducers, 3 3 ml squeeze flush, macrodrip (pole mount); lot #13998561 eight (8) new.List #425900405, transpac¿ iv trifurcated monitoring kit 60 inch, 3 disposable transducers, 3 3 ml squeeze flush, macrodrip (pole mount); lot #14035672 visual: the reported samples of twenty-seven (27) new list #425900405, transpac¿ iv trifurcated monitoring kits were received for evaluation.No visual anomalies were observed on the returned sets.Functional: when the returned sets were primed and pressure leak tested (equipment cal id: p-1g-079) per psp.X.Mk, no leaks were observed on all the sets.All the products had performed per the specifications.The complaint could not be confirmed.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.No visual anomalies were observed on the returned sets.When the returned sets were primed and pressure leak tested, no leaks were observed on all the sets.All the products had performed per the specifications.Without the return of the reported sample, the complaint could not be confirmed.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: 22070615
• Report Number: 9617594-2025-01085
• Device Sequence Number: 21010293
• Product Code: DRS
• UDI-Device Identifier: 00840619063184
• UDI-Public: (01)00840619063184(17)270501(10)14035672
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 14035672
• 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: 05/29/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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