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

Catalog Number UNKNOWN

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

The device was discarded.Without the returned device a probable cause can not be established.A device history review (dhr) is unable to be performed due to no lot number being provided.

Event Description

The event occurred on a unknown date in 2018.The event involved a tego connector with unknown list and lot number that the customer reported during treatment, the patient was not feeling well and the nurse observed a pool of blood under the patient¿s chair.The customer stated that the blood leak was from the disconnection between the venous line, baxter artiset hd dnl hc bloodline, and the tego connector.The treatment was stopped and the patient became unconscious.The medical intervention consisted of 800 ml of saline and 4 units of a blood transfusion.The patient was stabilized after the event and was sent back to the ward.There was no more information provided.

• Brand Name: TEGO
• 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: christopher zanoni ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 9727373
• MDR Text Key: 190681745
• Report Number: 9617594-2020-00047
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• 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: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Life Threatening; Required Intervention