MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP STERILE FX25RE OX W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RE

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

Terumo cardiovascular systems corporation has received the actual device for evaluation; however, the investigation has yet to be completed.A follow-up report will be submitted when the investigation is complete and/or more information becomes available.(b)(4).Evaluation, conclusions: conclusion not yet available-evaluation in progress.Product code: 45046 (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 when the oxygenator was taken out of box in the operating room, the port was found to be smashed.No patient involvement as this occurred out of box.Device was changed out.Procedure was not delayed.

• Brand Name: STERILE FX25RE OX W/ RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: robyn o'donnell ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5138634
• MDR Text Key: 27907032
• Report Number: 1124841-2015-00270
• 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
• Report Date: 10/08/2015

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: Other
• Device Expiration Date: 03/31/2018
• Device Model Number: 3CX*FX25RE
• Device Lot Number: TE27
• Other Device ID Number: (01)00699753450462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2015
• 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