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

Model Number 011-46110-71

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

The device was discarded at the user facility.A sample from the same lot number is returning for evaluation.

Event Description

The event involved a customer allegation of a transpac iv monitoring kit that leaked at a junction that was supposed to be bonded.After review of the customer provided image, a leak was noted at a bonded site located on the pressure tubing.There was no adverse event and no medical or surgical intervention required.

Manufacturer Narrative

One used, list # 011-46110-71, transpac® iv monitoring kit w/03 ml squeeze flush device, microclave®, 03 ml safeset¿ reservoir and blood sampling port; lot # 3421156 was received for testing and evaluation.As received, the monitoring kit was hydrostatically pressure leak tested and a leak was observed at the bond between the 24" arterial tubing and female luer.The tip of the arterial tubing was microscopically examined and it appears that insufficient solvent was present on one half of the tubing, leading to a channel leak.The reported complaint of tubing detaching from a junction was confirmed.A channel leak was observed between arterial tubing and a luer of the used sample.It appears that that there was insufficient solvent at this bond location.The probable cause for the leak is a manual manufacturing process error during bonding.A device history review (dhr) was completed and no non-conformances were noted that would have contributed to the reported complaint.

• Brand Name: TRANSPAC® IV MONITORING KIT
• Type of Device: TRANSPAC® IV MONITORING KIT
• 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
• MDR Report Key: 8011495
• MDR Text Key: 125675592
• Report Number: 9617594-2018-00145
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619070243
• UDI-Public: 840619070243
• Combination Product (y/n): N
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Model Number: 011-46110-71
• Device Catalogue Number: 011-46110-71
• Device Lot Number: 3421156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 10/28/2018
• Supplement Dates Manufacturer Received: 10/31/2018
• Supplement Dates FDA Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1