MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML F; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	42801-28
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending.
Event or Problem Description
The event occurred on an unknown date involving a transpac¿ it monitoring kit, 84" safeset reservoir, 2 blood sampling port, 3ml flush device, un-bonded macrodrip where the reporter stated that the art line malfunctioned and was reporting increasingly worsening hypertension, but with a good waveform and perfectly functional art line tubing/set.There was patient involvement but no adverse events.
Additional Manufacturer Narrative
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.The device history report (dhr) for lot 13979091 was reviewed and no non-conformities were found that would led to the reported complaint.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML F
• 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: 21413703
• Report Number: 9617594-2025-00316
• Device Sequence Number: 15507533
• Product Code: DRS
• UDI-Device Identifier: 00887709120778
• UDI-Public: (01)00887709120778(17)270401(10)13979091
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: 42801-28
• Device Lot Number: 13979091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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