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

Model Number 1CX*FX25E

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2014

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems corporation that prior to cardiopulmonary bypass, during prime, the fiber bundle from the fx25 oxygenator leaked.No pt involvement as this occurred during prime.Product was not changed out.The surgery was completed successfully.

Manufacturer Narrative

Terumo has not received the actual device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and more info becomes available.(b)(4).

• 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 CORPORATIONASHITAKA; 150
• Manufacturer Contact: robyn o'donnell, manager ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4361568
• MDR Text Key: 5292119
• Report Number: 9681834-2014-00349
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 130520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1CX*FX25E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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