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

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.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 11435886
• MDR Text Key: 238374388
• Report Number: 11435886
• 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: 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 Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: Y11925831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25915 DA