MAUDE Adverse Event Report: TERUMO CORPORATION CAPIOX; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 807518W

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anoxia (1711); Embolism (1829); Swelling (2091)

Event Date 01/09/2019

Event Type  malfunction  

Event Description

Noted white clots distal to arterial filter within the oxygenator of the bypass machine towards the end of the cardiopulmonary bypass case.Questions if it was possible thrombin or platelets.Patient's oxygenation and map remained stable throughout the surgery.Patient was slow to awaken postoperatively and it was felt he may have had an embolic stroke.Later testing indicated an embolic stroke, with micro embolism versus a major clot, along with increased swelling and a mass effect.The discharge summary noted anoxic encephalopathy.

• Brand Name: CAPIOX
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION; 125 blue ball rd.; elkton MD 21921
• MDR Report Key: 8343633
• MDR Text Key: 136296959
• Report Number: 8343633
• Device Sequence Number: 1
• Product Code: DTZ
• 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: 02/01/2019,01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 807518W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA