MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO® CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number D1000

Device Problem Fluid/Blood Leak (1250)

Patient Problems Chest Pain (1776); Hemorrhage/Bleeding (1888)

Event Date 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Event Description

The event occurred during hemodialysis (near the end of the dialysis run with 12 minutes remaining) and involved a tego® connector that was reported to have leaked blood onto the patient¿s blue pad from the device cap.There was no visible air in the line and the pad had blood covering approximately a 2"x5" area.The tego cap had a small slit that caused the blood to leak out.The patient then became unresponsive and had a short seizure.Oxygen (o2) was given by the nurse practitioners.The patient became responsive after approximately 10-15 seconds as her bp improved.She was complaining of chest pain and shortness of breath (sob).The staff took the patient to the er triage desk to be assessed.According to the employee, the tego cap failed which led to this situation.The impact of the incident was reported as a small amount of blood loss for the patient and the potential for an air embolism.An invasive procedure was not provided or not applicable.The patient had a right internal jugular tunneled cuffed catheter right (ij tcc) at the time of the event.

Manufacturer Narrative

One used.List #d1000, tego¿ connector, appx 0.05 ml; lot #unknown was received for investigation.The complaint of leakage could be confirmed on the returned used.List #d1000, tego¿ connector, appx 0.05 ml; lot #unknown.As received, the top of the silicone seal was domed.After decontamination the silicone seal returned to normal.The tego was disassembled to evaluate the probable cause of the domed seal.There was little to no adhesive observed on the side of the tego leading to the issue in doming which can lead to leakage.The probable cause of the seal doming and subsequent leakage is due to an assembly error in manufacturing where adhesive was not appropriately placed on the tego.A dhr (device history record) review could not be conducted because a lot number was not identified.Additional information can be found in h6 component codes.Correction: the d10 start dates and the d10 - end dates for both of the concomitant products recorded in the initial emdr should be 21-jul-2022 instead of 12-jul-2022.

• Brand Name: TEGO® CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15262500
• MDR Text Key: 305496298
• Report Number: 9617594-2022-00242
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

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 Model Number: D1000
• Device Catalogue Number: D1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/19/2022
• Supplement Dates Manufacturer Received: 08/22/2022
• Supplement Dates FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: LINES AV-SET ONLINE PLUS BVM 5008-R, MFR FRESENIUS; OXYGEN, MFR UNK
• Patient Sex: Female