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.For this reason, (b)(4) was referenced.(b)(4).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.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations and as indicated by terumo cardiovascular systems.The actual sample was returned for inspection.Visual inspection found that the blood outlet port was cracked.No other anomalies were noted on the device.A review of the device history record revealed no anomalies occurred during manufacturing.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations and as indicated by terumo cardiovascular system in the initial report submitted to the fda on october 8, 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 additional information); while submitting the initial report to the fda for this complaint, a system error occurred which resulted in a second, duplicate initial report to be submitted.Therefore, please reject mfr # 1124841-2015-00270.All pertinent information concerning this complaint has been properly reported to the fda in mfr # 1124841-2015-00273.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• 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: 5138818
• MDR Text Key: 28202293
• Report Number: 1124841-2015-00273
• 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
• Type of Report: Followup,Followup
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• 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
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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