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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION CAPIOX OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
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.
 
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Brand NameCAPIOX
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
TERUMO CORPORATION
125 blue ball rd.
elkton MD 21921
MDR Report Key8343633
MDR Text Key136296959
Report Number8343633
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received02/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number807518W
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/01/2019
Event Location Hospital
Date Report to Manufacturer02/15/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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