MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MAC; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	425850405
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a transpac® iv monitoring kit, 84", disposable transducer, 3 ml squeeze flush, macrodrip.The reporter stated that drip chamber was leaking, when the device was actively being used for monitoring a patient's central venous pressure (cvp) on a central line.Patient care was delayed while staff swapped out the device.There was no report of any human harm associated with this complaint/event.
Additional Manufacturer Narrative
The following was provided by the customer for complaint investigation: -one used partial list #425850405, transpac® iv monitoring kit, 84", disposable transducer, 3 ml squeeze flush, macrodrip; lot #13637041 the reported complaint of leakage was confirmed on the returned set.No visual anomalies were observed on the returned set.When the returned set was primed and pressure leak tested, a channel leak was observed between the pvc tubing and the drip chamber.The tubing and the luer tubing pocket was microscopically examined and insufficient solvent coverage was observed on the pvc tubing.The probable cause of the leakage had occurred due to insufficient solvent coverage between the pvc tubing and the drip chamber luer during manufacturing assembly.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC® IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MAC
• 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: 21187946
• Report Number: 9617594-2025-00140
• Device Sequence Number: 8546275
• Product Code: DRS
• UDI-Device Identifier: 00840619033804
• UDI-Public: (01)00840619033804(17)260501(10)13637041
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2025

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 Expiration Date: 05/01/2026
• Device Catalogue Number: 425850405
• Device Lot Number: 13637041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 01/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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 CENTRAL LINE, MFR UNK.
• Patient Sex: Unknown