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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Lot Number Y11925831
Device Problems Increase in Pressure (1491); No Flow (2991); Noise, Audible (3273)
Patient Problem Insufficient Information (4580)
Event Date 02/09/2021
Event Type  malfunction  
Event Description
Patient was on bypass support. Perfusionist heard squealing noise and saw a high pressure alarm. Notified or team there is no arterial flow. She continued to trouble shoot the circuit of heart lung bypass machine. She started to hand crank the pump which did not initially work either but flow started after a short time. A second perfusionist brought in a second pump machine and started to prime the circuit. Cardiac fellow performed compressions on patient. Circulating nurse took over hand cranking the failed pump machine while head perfusionist assisted the backup perfusionist to change out the old pump machine for the newly primed machine. Flow was maintained with new cannulation tubing. Device was cleaned and sequestered. Biomed checked the pump and could not duplicate any problems. Terumo inspected the next day. Condensation was noted on magnet side of the centrifugal head disposable that fits into the motor. Manufacturer response for perfusion system and centrifugal head - reservoir (per site reporter). Verified system was cleaned and brought to clinical technologies shop. Terumo was notified and came in the next day to pull the logs and inspect the system. Per system check no issue found. Terumo reviewed the logs and determined system performed as it should. They initially said it could go back into use but now have asked for the control unit to be sent in. They are also providing a biohazard box for the disposables to be returned.
 
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Brand NameCAPIOX FX OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
TERUMO CORPORATION
950 elkton blvd
elkton MD 21921
MDR Report Key11435886
MDR Text Key238374388
Report Number11435886
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 Other Health Care Professional
Type of Report Initial
Report Date 02/24/2021,02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot NumberY11925831
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/24/2021
Event Location Hospital
Date Report to Manufacturer03/08/2021
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 Unkown

Patient Treatment Data
Date Received: 03/08/2021 Patient Sequence Number: 1
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