MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS STERILE FX25RW OXY W/ RESERVOIR; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RW

Device Problem Dent in Material (2526)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2015

Event Type  malfunction  

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 complete and more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during setup, the venous inlet of the oxygenator was dented.There was also a tear in the blue inlet port caps.No patient involvement as this occurred during setup.Product was changed out.Surgery as completed successfully without delay.

Manufacturer Narrative

This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on december 23, 2015.Upon further investigation of the reported event, the following information is new and/or changed: (date received by manufacturer).(indication that this is a follow-up report).(follow-up due to device evaluation).(device evaluated by manufacturer).(b)(4).The actual sample was visually inspected upon receipt, during which it was confirmed that there was damage to the blood inlet port of the oxygenator and to the cardiotomy port cap on the reservoir lid.No other damages were noted on the device.A review of the device history record revealed no anomalies.All units are 100% visually inspected during final assembly and packaging.The damage to the port and cap was most likely due to an extreme external force being applied to the product at some point after final release, during shipping and handling; however, a definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: STERILE FX25RW OXY W/ RESERVOIR
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: robyn o'donnell ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5323940
• MDR Text Key: 34277940
• Report Number: 1124841-2015-00338
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

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 Expiration Date: 08/31/2018
• Device Model Number: 3CX*FX25RW
• Device Lot Number: TL28
• Other Device ID Number: (01)00699753450479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2015
• 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