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

Catalog Number D1000

Device Problems Disconnection (1171); Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 04/13/2023

Event Type  Death  

Manufacturer Narrative

The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.

Event Description

The event involved an unspecified tego connector in which the customer reported that a female, home patient died.The device was used with unspecified baxter products.The customer reported that the patient did not follow the nurses security procedures on dialysis; no hemaclip (device to hold the blood lines arterial/venous connection on the catheter) or parkline (device to securely hold the blood lines) were used during this last treatment.The patient was found with arterial bloodline disconnected, tego® connector not on the catheter but on the bloodline.The customer reported that it appeared that air has been introduced in the catheter and that the arterial bloodline was practically emptied and coagulation in the venous bloodline.There was dry blood observed on the bed and on the floor; according to the nurse it could be from the digestive hemorrhage.

Manufacturer Narrative

See b5 section.

Event Description

Additional information was received from the customer stating that they do not have a sample with the batch number but that they may be able to provide sample but would probably not be from the same lot number.Customer also stated that the patient's death was classified as natural death by the physician in charge of the file.

Manufacturer Narrative

A single new in package of d1000 tego sister sample was returned for investigation.There was no visible damage or anomalies observed with the d1000 tego.No mating devices were returned to evaluate with the d1000 tego connector.Subsequent testing and measurement showed the new d1000 tego connector to meet dimensional and product performance expectations without leakage or propensity to disconnect.The complaint as related to the d1000 tego was unable to be confirmed.Two photos were returned for evaluation; the first photo showed a d1000 tego connected between what appears to be the blue male luer of a blood set and the blue female luer of a catheter.There was no visible damage or anomalies observed with the d1000 tego.The second photo showed a new in package d1000 tego.There was no visible damage or anomalies observed with the d1000 tego.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - sister sample was received for evaluation on 11 july 2023.

• 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: 16797236
• MDR Text Key: 313844054
• Report Number: 9617594-2023-00150
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: D1000
• Device Lot Number: 13481741
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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: UNSPECIFIED BAXTER PRODUCTS
• Patient Outcome(s): Death
• Patient Age: 38 YR
• Patient Sex: Female