MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25REC

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the 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 when more information becomes available.For this reason, terumo references evaluation conclusion.(b)(4).Conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular systems corporation that prior to cardiopulmonary bypass, while unboxing the product, the c-ring that secures the reservoir to the oxygenator had popped off.It could not be put back on as it was too tight.*no patient involvement as this was found out of box.

Manufacturer Narrative

The returned sample was visually inspected and it was found that the c-ring on the sample, that holds the neck to the reservoir, was not in place.No damages were noted anywhere on the device.The c-ring was able to be put back into place; however, it seemed to be a loose fit and easily removed again.A retention sample from product code 3cx*fx25rec lot tp14 was obtained and confirmed to have the c-ring in its proper place.The c-ring was then able to be manually detached from the device and put back into place.The connection of the c-ring to the neck seemed to be more secure than that of the returned complaint sample.Each connecting ring is put into place using a mechanism on the reservoir leak tester in production.The leak test will not start until the handle is positioned properly over the connecting ring indicating that it has been properly put in place attaching the reservoir to the lid.All products are 100% visually inspected to ensure that the connecting ring is fully seated at each side and there isn't a loose connection.It is possible that there had been some damage to the c-rings at some point during the production process or shipping and handling that caused them to have a loose connection on the product.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: STERILE FX25REC 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 ; 8002837866
• MDR Report Key: 5460583
• MDR Text Key: 39035652
• Report Number: 1124841-2016-00071
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: TM28
• Other Device ID Number: (01)00699753450820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• 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