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

Catalog Number D1005

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

Samples are available for evaluation.They are yet to be received.

Event Description

The customer reported a tego connector became disconnected during continuous renal replacement therapy (crrt) resulting in a blood loss of 1400mls.The patient required emergency blood transfusion with 2 units of packed red blood cells (prbc) and increased vasopressor dose.Per the vascular sales specialist, event was not due to a quality issue with the tego but rather the addition of a bd stopcock that was not compatible with the tego thus resulting in high pressures during crrt.The stopcock was very basic and a spin male luer that didn¿t fully secure to the tego.No additional information has been provided.

Manufacturer Narrative

Concomitant products: common device name: dialyzer, high permeability with or without sealed dialysate system.Mfr: nxstage medical, inc., 350 merrimack st., lawrence, ma, 01843, model number: nx-1000-5-a, serial number: (b)(6), brand name: nxstage system one, age of device: 2 years.Common device name: stopcock, i.V.Set, brand name: bd connecta plus stopcock, mfr: bd, san antonion, tx, model number: 394910, catalog number: 394910.

Event Description

Ufmw received on october 2, 2019.¿staff description: pt became disconnected from return port of continuous renal replacement therapy (crrt) and was pumping blood into the bed.No alarms went off on circuit.Disconnection was noted when blood pressure dropped.Crrt was stopped and lines were clamped.There appeared to be several hundred ml of blood in the bed.Blood pressure stabilized with increased pressors and stopping of crrt.Machine brought to clinical technology for evaluation.Sent log file to manufacturer for review.Verified parameters.Prime and alarms tests-passes.Mock treatment.Triggered venous high pressure to test audible alarm-audible alarm occurred.Machine appears to be working per specifications.According to the machine log, the venous return pressure was around 90mmhg just prior to disconnect.Pressure then dropped to around 36mmhg.Alarm limit was set at 20mmhg.Blood flow rate was 200ml/min.Blood loss estimate was around 1000ml.A key factor appears to be the use of the tego port and the 3-way stopcock on the venous return line.The stopcock was a newly introduced model and may be more prone to not locking properly on the threads.The line disconnected where the stopcock was attached to the tego port.Another factor is the small bore of the stopcock and tego connector provided enough back pressure to prevent the low pressure alarm from triggering.¿.

Manufacturer Narrative

H10: no d1005 product samples, videos, or photographs were returned for investigation.No dhr lot review was conducted because no lot number(s) was/were identified.A probable cause cannot be identified based on the information that has been provided.Additional information in d10 and g1.

• 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: 8902778
• MDR Text Key: 154849684
• Report Number: 9617594-2019-00278
• Device Sequence Number: 1
• Product Code: FPA
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D1005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BD STOPCOCK.
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR