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

Model Number 011-46103-88

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation not complete.

Event Description

The event involved customer report of a transpac tubing set that separated at luer lock connection.It was further reported that the tubing set fell apart during set-up.

Manufacturer Narrative

One (1) used partial set transpac® iv bifurcated monitoring kit was received for evaluation.Testing found arterial tubing separation, between the 12" tubing and female luer.The tubing and all molded parts were within specifications with nothing to indicate an insufficient amount of bonding.A representative bond was pull tested and also met specifications.The cause for the separation cannot be determined.

• Brand Name: TRANSPAC® IV BIFURCATED MONITORING KIT
• Type of Device: TRANSPAC® IV BIFURCATED 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: 7187345
• MDR Text Key: 97748944
• Report Number: 9617594-2018-00004
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011-46103-88
• Device Catalogue Number: 011-46103-88
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2018
• Patient Sequence Number: 1