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

Catalog Number 011-46115-21

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/13/2023

Event Type  malfunction  

Event Description

The event involved a transpac where it was reported that when flushing the hep saline there was leaking from where syringe safe set connects to the line.Blood then tracked back up the line to the safe set syringe.The issue was resolved by removing affected product from use.The root cause was identified and it was a faulty bonding in safe set.There was patient involvement but no patient harm.This captures 2 of 2 occurrences.

Manufacturer Narrative

The device is available for evaluation, however has not been received.

Manufacturer Narrative

Received one used.List #011-46115-21, transpac® iv monitoring kit w/03 ml squeeze flush device, microclave®, 03 ml safeset¿ reservoir and blood sampling port; lot #13612950.--> one used.List #unknown, terumo 60 ml syringe with heparin; lot #unknown.During visual inspection, unknown solution residuals were observed on the safeset reservoir luer.When the returned set was primed and pressure leak tested, a channel leak was observed between the safeset reservoir and the plug stopcock.The plug stopcock and the sefeset reservoir separated after the pressure leak test.When the plug stopcock was microscopically examined, adhesive coverage was missing on one portion of the stopcock.The probable cause of the channel leak had occurred due to missing adhesive coverage on the plug stopcock during assembly.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to manufacturer on 11/16/2023.

• Brand Name: TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAF
• 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: 17835562
• MDR Text Key: 324497992
• Report Number: 9617594-2023-00770
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619094010
• UDI-Public: (01)00840619094010(17)260401(10)13612950
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-46115-21
• Device Lot Number: 13612950
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• 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
• Treatment: HEP SALINE, UNK MFR