MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV W/03 ML SQUEEZE FLUSH DEVICE, 60" MACRO ADMIN SET AND PRESSURE TUBI; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46106-74

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  malfunction  

Event Description

The event involved a transpac® iv w/03 ml squeeze flush device, 60" macro admin set and pressure tubing (152cm) where it was reported that during the time of infusion, that a leak was observed between the tubing that comes from the bag and the luer lock which is screwed onto the sensor block.The patient found himself soaked even though the artery curve works very well.The tubing was changed.No harm reported.The event was noticed at distance because the patient and the sheets were very wet.The leak was at the weld level between the tubing and the luer lock screw, upstream of the sensor.This is the connection at the sensor level.Therefore in contact with the solute in overpressure.The leak was noticed several hours after installation.Concerning the 2 cases.There was no real loss of medication, just ssi with heparin.No visible default on the device before use.At the time of the leak, we cannot see the hole but the leak is visible with drops forming continuously, liquid under pressure.This is the first of two occurrences.

Manufacturer Narrative

A physical sample is not available however a photo was provided and will be used for the investigation.

Manufacturer Narrative

The reported complaint could not be confirmed.No product samples, videos were returned for investigation.However an image was provided by the customer showing the involved product inside the packaging.A failure mode was not able to be identified with the image provided by the customer.Therefore, a comprehensive failure investigation cannot be performed and a cause cannot be determined.A manufacturing record review could not be completed as the lot number was not provided by the customer.

• Brand Name: TRANSPAC® IV W/03 ML SQUEEZE FLUSH DEVICE, 60" MACRO ADMIN SET AND PRESSURE TUBI
• Type of Device: 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: 18853274
• MDR Text Key: 337766691
• Report Number: 9617594-2024-00236
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-46106-74
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEPARIN., MRF UNK