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

Catalog Number D1000

Device Problem Disconnection (1171)

Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

The device involved in the event was discarded; however, a device from the same lot number is available to be returned.It is yet to be received.

Event Description

The customer reported a tego connector came off a patient during treatment.He exsanguinated to a bp of 50/-.The medical intervention provided was dialysis was stopped.The patient was given fluid resuscitation and a medical emergency team (met) call was made.Blood samples were taken.No blood transfusion was required.The patient was admitted to the hospital overnight with no ongoing effects.Dialysis recommenced the following day.The patient and family received counselling.Hospital administration was notified of the event and follow up.The estimated blood loss is 600ml.The disconnection occurred between the tego and the venous iv tubing coming from the dialysis machine, returning blood to the patient and the tego connector.The nurse unit manager believes the connection had not been properly made at treatment set-up/initiation between the line and the tego.This is the second disconnection involving the same nurse.It was reported that the product was used per the instructions for use.The patient is fine now.

Manufacturer Narrative

H10: one (1) new list# d1000, tego¿ connector, lot # 4158238 was received on (b)(6), 2020 for evaluation.The complaint of disconnection on the returned new d1000 tego could not be confirmed or replicated.The returned new d1000 tego was leak tested per product specification.There were no leaks anywhere along the fluid path.The device was attached to a icu medical provided syringe and a retention test was performed.The syringe did not separate from the tego per product specification.100 samples of a finished good lot with same sub assembly lot number was measured.Each device met product specification.The used device mention in the complaint was not returned for evaluation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.A device history review for lot# 4158238 and relevant commodities were reviewed and no non-conformances were found that would have contributed to the reported complaint.

• 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
• MDR Report Key: 9644346
• MDR Text Key: 177177486
• Report Number: 9617594-2020-00028
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)240701(10)4158238
• Combination Product (y/n): N
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D1000
• Device Lot Number: 4158238
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS LIFELINE DIALYSIS TUBING
• Patient Outcome(s): Life Threatening; Required Intervention