MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS BIOMEDICUS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96820-112

Device Problem Device Slipped (1584)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Pulmonary Edema (2020); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/15/2022

Event Type  Injury  

Event Description

Attempted wean, patient tolerated decreased flows with adequate perfusion and lactate.Underwent a clamping trial for 1 hour during which patient had increased pco2's (partial pressure of carbon dioxide) and lower pao2 (partial pressure of oxygen) requiring increased ventilatory support.Patient was noted to have increased bloody output from the et tube and there was concern for worsening pulmonary edema vs new pulmonary hemorrhage.A chest x-ray was ordered but was unable to be completed due to concern from ecmo perfusionist and ecmo rn for possible clotting in the arterial cannula, which upon inspection came out of the neck, and a ecmo code was initiated.Patient had an arrest necessitating cpr and massive transfusion protocol.Patient underwent a successful resuscitation and was recannulated back onto va ecmo.Grommet around arterial catheter did not hold catheter in place, arterial catheter slipped through grommet and out of carotid artery.Patients' sedation was "light" required multiple boluses of ketamine and fentanyl during bridge clamp trial off ecmo when event occurred.

• Brand Name: BIOMEDICUS
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 8200 coral sea street ne; moundsview MN 55112
• MDR Report Key: 15931251
• MDR Text Key: 304968952
• Report Number: 15931251
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 96820-112
• Device Catalogue Number: 96820-112
• Device Lot Number: 218689017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2022
• Date Report to Manufacturer: 12/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 730 DA
• Patient Sex: Female