MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 1 LINE, 1 TRANSDUCER 60" (152CM) 3 ML/HR MACRODRIP; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-0P229-01

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Separation Problem (4043)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is not yet received.

Event Description

The event occurred on an unspecified ate and involved a 1 line, 1 transducer 60" (152cm) 3 ml/hr macrodrip.The customer stated that the nurses in the intensive care unit reported that a leak occurred at the junction of the tubing connected to the bag / rigid plastic part.The customer said that it appeared to be more of a separation than a breakage.The leak occurred quickly after the set up.Customer further reported that there was no change in the patient's condition, he was calm.There was no need of medical intervention and no blood loss.No physical default was observed on the device before use.The device was changed out.There was patient involvement; harm was not reported as a consequence of this event.

Manufacturer Narrative

The device was returned for evaluation on 3/6/24.The reported complaint of separation was confirmed on the returned set.Images were provided by the customer showing the pvc tubing separated from the transpac luer pocket.During visual inspection of the sample, the pvc tubing was found separated from the transpac luer pocket.When the tubing pocket was microscopically examined insufficient adhesive coverage was observed.The probable cause of the separation had occurred due to insufficient adhesive coverage applied on the tubing during assembly process.Lot history review and relevant commodities were reviewed; no discrepancies were found.

• Brand Name: 1 LINE, 1 TRANSDUCER 60" (152CM) 3 ML/HR MACRODRIP
• 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: 18803027
• MDR Text Key: 337484698
• Report Number: 9617594-2024-00213
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052828
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-0P229-01
• Device Lot Number: 13712100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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
• Patient Sex: Male