MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RW OX W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RW

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

The complaint was confirmed upon completion of the investigation.Visual inspection confirmed that the blood inlet port on the oxygenator was damaged, however no additional damage was observed.A retention sample was visually inspected, and no anomalies were noted.A review of the device history record revealed no production related anomalies.The product is 100% visually inspected during manufacturing.The damage to the port was likely due to shock force post manufacturing; however the cause of the damage is unknown.(b)(4) all available information has been placed on file in quality management for appropriate tracking, trending and follow up.

Event Description

The user facility reported to terumo cardiovascular systems corporation that prior to cardiopulmonary bypass, during setup, it was found that the blood inlet port cap on the oxygenator was difficult to remove.The cap was torn and the port was damaged.No patient involvement as this occurred during setup.Product was changed out.Surgery was completed successfully.

• Brand Name: STERILE FX25RW OX W/ RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5477755
• MDR Text Key: 39817055
• Report Number: 1124841-2016-00090
• 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,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 3CX*FX25RW
• Device Lot Number: TN30
• Other Device ID Number: (01)00699753450479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2015
• 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