MAUDE Adverse Event Report: MEDTRONIC, INC. INTERSEPT; TUBING, PUMP, CARDIOPULMONARY BYPASS

Lot Number 216211872

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Exsanguination (1841)

Event Date 08/25/2019

Event Type  malfunction  

Event Description

Around 2000, primary rn noticed some leaking from around the y-connecter on the ecmo circuit.At this time, perfusion was notified as well as the md.The md then notified the covering surgeon that there was leaking around the y-connecter that connects the lv vent to the venous drainage line, it was relayed to the surgeon that the md was concerned that it was either a loose connection or that one of the lines was fractured.The surgeon recommended adding a zip tie and bonewax to fix the leak.Around 2100, when perfusion went into the room to carry out this plan, the y-connecter broke and the patient began to exsanguinate, md called to beside at this point, flows were lost and cpr was initiated.Simultaneously, surgeon was made aware, the ecmo cannula was clamped, mass transfusion protocol was initiated, the patient was intubated and a line was place.Perfusion was able to replace the y-connecter and reestablish flow on the ecmo circuit.Shortly after this, the surgeon arrived to the patient's room.Type of equipment: other.Manufacturer: medtronic inc.Name of device: intersept tubing connector.Lot number: 216211872.Expiration: 9/19/2020.Type of device involved in event? medical equipment (non-implantable).Was device placed within patients tissue? no.Did the event result in the device being removed? device was removed and a new one placed on patient.Which of the following best describes the event or unsafe condition? device failure.Did the event involve reuse of a device intended for single use? no.Was the device removed from service? no.Operator of the device: health professional.

• Brand Name: INTERSEPT
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy.; minneapolis MN 55432
• MDR Report Key: 9259901
• MDR Text Key: 164454032
• Report Number: 9259901
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 216211872
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14600 DA