MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ TRIFURCATED MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLIN; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	426500406
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a transpac¿ trifurcated monitoring kit with safeset¿ reservoir and 2 blood sampling ports, 84", 3 3 ml squeeze flushes, 3 disposable transducers, macrodrip (pole mount) and occured on an unspecified date.It was reported that the device had a "broken art line kit".There was patient involvement and harm/adverse event report.The patient was found bleeding profusely from his arm.No additional information was provided on this case.
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.
Additional Manufacturer Narrative
The complaint could not be confirmed.No product samples, or videos were received for investigation.However, images were provided by the customer showing the tubing separation and the label.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.Lot history review was performed and no non-conformities were found that would led to the reported complaint.

• Brand Name: TRANSPAC¿ TRIFURCATED MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLIN
• 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: 19652576
• Report Number: 9617594-2024-00861
• Device Sequence Number: 6483790
• Product Code: DRS
• UDI-Device Identifier: 00840619045029
• UDI-Public: (01)00840619045029(17)270101(10)13887323
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 426500406
• Device Lot Number: 13887323
• 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: 06/07/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown