MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH MAQUET ECMO CIRCUIT; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number BEQ-015703112

Patient Problems Exposure to Body Fluids (1745); Hemorrhage/Bleeding (1888)

Event Date 01/31/2024

Event Type  Injury  

Event Description

Patient was converted to new vv ecmo circuit in the operating room.Very shortly after being on new circuit the perfusionist noted small amount of blood coming out of the oxygen vent port at the bottom of the oxygenator.Blood never interfaces with any of the gas or fluid lines inside an oxygenator.As soon as this blood was noted the cardiac surgeon was notified immediately and a new ecmo circuit was placed on the patient.The defective circuit was sequestered and the local maquet/getinge rep was notified.The company is sending a special biohazard shipping kit so that we can send the defective equipment back to the manufacturer for analysis.There was no noticeable harm to the patient, but blood cultures were drawn for due diligence to ensure no contamination of blood occurred.

• Brand Name: MAQUET ECMO CIRCUIT
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH
• MDR Report Key: 18660774
• MDR Text Key: 334897335
• Report Number: MW5151132
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BEQ-015703112
• Device Lot Number: 3000345324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No