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

Catalog Number 01C-42584-05

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/21/2024

Event Type  malfunction  

Event Description

The complaint/event involved a transpac® iv monitoring kit, disposable transducer, 03 ml squeeze flush, macrodrip.The reporter stated that the product has been used for many years and has good performance.The patient's arterial blood pressure was being continuously monitored with the device.After approximately 10 minutes or so, the nurse reportedly found blood reflux and water stains on the bed sheet.Inspection found leakage at the sensor connected screw part, immediately shut down and replace the pressure sensor of the same brand and batch specifications.Arteriovenous catheterization was smooth in place at the time.The pressure sensor kit was not tightened and it still leaked after tightening, as the pipe was not sealed.The process as immediately shut down and the pressure sensor was replaced with the same brand and batch specifications.There was no harm or clinical consequences reported with respect to this complaint/event.

Manufacturer Narrative

The device is not available for investigation.Without the return of the device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.

• Brand Name: TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODR
• 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: 18759850
• MDR Text Key: 336420321
• Report Number: 9617594-2024-00179
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01C-42584-05
• Device Lot Number: 5889757
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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: UNSPECIFIED ARTERIOVENOUS CATHETER, MFR UNK
• Patient Age: 75 YR
• Patient Sex: Female