MAUDE Adverse Event Report: TERUMO CARDIVASCULAR SYSTEMS TERUMO CAPIOX FX25; OXYGENATOR

Lot Number 131010

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Date 06/03/2014

Event Type  Injury  

Event Description

Patient at the hospital for an aorto-coronary bypass on (b)(6) 2014.During the procedure and while the surgeon was attempting to place the patient on the bypass pump the oxygenator on the heart and lung machine failed to operate correctly.The perfusionist said the device had less than satisfactory oxygen levels.Problem was noticed by perfusionist immediately and informed the surgeon of the problem.The crossclamp had not been applied yet.Anesthesiologist continued to bag the patient.All connections were checked so again the team tried to go on bypass but the oxygen level fell again.Anesthesia continued to bag the patient.An oxygen tank was brought into the room and wall oxygen was bypassed (to rule out an oxygen supply problem) and again the same situation happened.Going on the pump was temporarily suspended while perfusionist changed out the oxygenator.After the oxygenator was replaced and verified that it was working properly the patient was placed on the pump with no problems noted.Patient was discharge on (b)(6) 2014 to his home.Have been in contact with (b)(4) from terumo requesting device for testing.

• Brand Name: TERUMO CAPIOX FX25
• Type of Device: OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIVASCULAR SYSTEMS; 6200 jackson rd; ann arbor MI 48103 930
• MDR Report Key: 3891260
• MDR Text Key: 18030817
• Report Number: 3891260
• Device Sequence Number: 1
• Product Code: DTZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Lot Number: 131010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2014
• Distributor Facility Aware Date: 06/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 70 YR