MAUDE Adverse Event Report: TERUMO CORP. FX OXY W/O RESERVOIR; BLOOD GAS OXYGENATOR

Model Number 1CX*FX25W

Device Problem Use of Device Problem (1670)

Patient Problems Neurological Deficit/Dysfunction (1982); Blood Loss (2597)

Event Date 02/13/2014

Event Type  Injury  

Manufacturer Narrative

Terumo has received the actual device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is completed and more information becomes available.(b)(4).

Event Description

On (b)(6) 2014, a patient was undergoing a very long (greater than 4 hours) re-do cabg x4 (coronary artery bypass graft) procedure.Approximately 3 hours into cpb, the arterial pa02 gradually dropped and the pac02 gradually increased.The fi02 and gas flow were raised to compensate for the degrading values.The oxygenator was changed out, after approximately 252 minutes on bypass, while additional veins were harvested for the procedure.Cpb was reinstated within 15 minutes.Estimated blood loss from the change out of the oxygenator was approximately 300ml.It was noted from the pump records that the recirculation line of the perfusion circuit was opened for periods of time on multiple occasions to recycle blood back through the oxygenator in order to increase the pa02 and decrease the pac02 in the blood.The procedure was completed as scheduled.Cpb was halted to a period of 15 minutes to harvest more vein to allow for the bypass of another coronary artery.The patient was noted to have some neurological deficit after the procedure; however, the patient later returned to full function.The patient was discharged to home on (b)(6) 2014.

• Brand Name: FX OXY W/O RESERVOIR
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CORP.; ashitaka, 150 maimaigi-cho; fujinomiya city, shizuoka, prefecture 418 ; JA 418
• Manufacturer (Section G): TERUMO CORP.; ashitaka, 150 maimaigi-cho; fujinomiya city, shizuoka, prefecture 418 ; JA 418
• Manufacturer Contact: eileen dorsey, manager ; 125 blue ball rd; elkton, MD 21921 ; 8002623304
• MDR Report Key: 3724503
• MDR Text Key: 15880122
• Report Number: 9681834-2014-00061
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2016
• Device Model Number: 1CX*FX25W
• Device Lot Number: 130909
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/24/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other