MAUDE Adverse Event Report: ICU MEDICAL, INC. TEGO CONNECTOR

Model Number D1000

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

Initial investigation: a review of the mfg.Lot database for the reported lot# 3255850 (mfg.05/2016) showed (b)(4) units were mfg.Tested, inspected and released.There were no exception documents generated during the lot build.Device return: one used d1000 tego connector; thirty-five packaged d1000 tego connector lot# 3255850; one used tubing segment/male luer.Qe investigation in progress.Upon fda request, this report is being resubmitted electronically.

Event Description

Int'l.((b)(6)) complaint received reporting leakages/air in lines with use of d1000 tego connectors.The initial information received reports "patient had a new tego installed.Patient was connected the dialysis unit post.Arterial line was immediately noted to be filling with "frothy" blood.Tego tightened and examined.No resolution.Therefore, session was immediately stopped.Blood not returned.New tego installed from a different lot.No further evidence of air being drawn from the environment noted with the new tego.".Blood loss (est.50mls) was reported, however cbc/standard blood work confirmed stable hemoglobin, patients health status unchanged.

• Brand Name: TEGO CONNECTOR
• Type of Device: TEGO CONNECTOR
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 6298798
• MDR Text Key: 251101819
• Report Number: 2025816-2016-00154
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: D1000
• Device Catalogue Number: D1000
• Device Lot Number: 3255850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2016
• 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
• Patient Age: 61 YR
• Patient Sex: Female