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

Catalog Number LAT-D1000

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

The device is reported to be discarded and is not available for evaluation.Without the return of the sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.If additional pertinent information becomes available, a supplemental report will be submitted.

Event Description

The event involved a tego connector which was attached to the arterial lumen and presented blood leakage from a slot.The patient was admitted to the hemodialysis room, assigned and transferred to the chair and the machine ready for use; the first vital signs were checked and recorded.The device was programmed according to the medical prescription as follows: qb 330 ml/min, qd 500 ml/min, with duration of 4:00 hours, dry weight (b)(6) kg, uf rate 7.4 ml/kg/ hour, anticoagulation with sodium heparin 5000 international units.The dialysis was initiated through the right jugular catheter, covered with a dressing, which was seen to be clean, without signs of infection.Asepsis was performed according to protocol and the backflow was tested in both lines, without issues.The heparinization of the extracorporeal system was performed for 3 minutes and hemodialysis was started according to the medical prescription.The arteriovenous lines were connected to the tego connector by screwing the spinning collar of the blood tube onto the connector, until it stopped and was secured.After less than 1 minute of therapy, the hemodialysis machine emitted an alarm of a decrease in blood pressure reaching -220, which could be indicative of a dysfunctional catheter.The catheter was observed to be bent, which could be causing the obstruction, readjustment maneuvers were performed, and the av lines were switched.The atrioventricular (av) lines were again attached to the tego connector, and when the therapy re-started; blood loss (less than 150 ml ) was generated through a slot in the tego connector attached to the patient's arterial lumen.The tego connector was changed by one of the same reference.All connections were verified to be properly adjusted, the patient was re-connected, and therapy was resumed without any other issues.There was no harm reported as a consequence of this event.

• Brand Name: CONECTOR 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 11594833
• MDR Text Key: 244179137
• Report Number: 9617594-2021-00104
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00887709096271
• UDI-Public: (01)00887709096271(17)240801(10)4354306
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LAT-D1000
• Device Lot Number: 4354306
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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: 75 YR
• Patient Weight: 77