MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IV MONITORING KIT WITH SAFESET; TRANSPAC® IV MONITORING KIT WITH SAFESET¿

Model Number 01C-42640-06

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Testing and investigation confirmed the complaint of leakage.The device was pressure leak tested at 9psi.A leak was observed between the uv bonded 2-way stopcock and the safeset reservoir syringe.The uv bond is visible at this luer connection, with no physical damage or channel leaks observed.The leak was confirmed but the cause cannot be determined.A review of lot# 3406820 showed (b)(4) units were manufactured, tested, inspected and released in march 2017, citing no exception documents.

Event Description

The event involved a customer report that a transpac tubing set was leaking during infusion.The was in use approximately 1 - 2 hours.It was reported that there were no interventions aside from routine change were required and that the device was replaced and no further problems were encountered.There was no adverse event or delay in critical therapy reported.

• Brand Name: TRANSPAC IV MONITORING KIT WITH SAFESET
• Type of Device: TRANSPAC® IV MONITORING KIT WITH SAFESET¿
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, 22790 ; MX 22790
• Manufacturer (Section G): ICU MEDICAL, INC.; 600 n. field drive, bldg h2-2n; lake forest IL 60045
• Manufacturer Contact: regina rose ; 600 n. field drive, bldg h2-2n; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 7224789
• MDR Text Key: 98550192
• Report Number: 9617594-2018-00006
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619037475
• UDI-Public: 840619037475
• 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: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: 01C-42640-06
• Device Catalogue Number: 01C-42640-06
• Device Lot Number: 3406820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1