MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH DEV; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	46115-51
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The complaint/event involved a transpac® iv monitoring kit, 60", disposable transducer, 03 ml squeeze flush device, macrodrip un-bonded that reportedly generated a dampened waveform (potentially inaccurate readings/results) during a patient's infusion of unspecified fluids in the ccu.The tubing was replaced.There was no hole, cut, tear, any crack, disconnection or separation noted.There was no human harm and no delay in therapy reported.
Additional Manufacturer Narrative
Investigation summary: the reported complaint of transducer dampening was not confirmed.No visual anomalies were observed.When the transpac was electrically tested, and a wave form was able to be zeroed with the waveform visible on the monitor.However, the transpac iv set was tested for continuous flow rate, when the pull flush is in an inactivated state, the sample failed to meet specification requirements.The directions for use specifies that a 30 ml transpac iv set must be used with a pump.The 3 ml set is not intended for use with infusion pumps.The probable cause of the increased pressure alarm had occurred due to the use of a 3 ml transpac iv set in a pump application, contrary to its intended use.A device history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: TRANSPAC® IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH DEV
• 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: 22029177
• Report Number: 9617594-2025-01008
• Device Sequence Number: 15498202
• Product Code: DRS
• UDI-Device Identifier: 00887709086128
• UDI-Public: 00887709086128
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: 46115-51
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: UNSPECIFIED FLUIDS, MFR UNK.
• Patient Sex: Unknown