MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RWC

Device Problem Material Distortion (2977)

Patient Problem No Patient Involvement (2645)

Event Date 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, 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.(b)(4).Results - results pending completion of evaluation.Conclusions - conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the venous inlet on a fx25 oxygenator became distorted.  no patient involvement; product was changed out; procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on nov 1, 2017.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.U the returned sample was visually inspected.It was found that the blood inlet port on the oxygenator was dented inwards.There were no other anomalies noted anywhere else on the product.A retention sample was obtained from the same product cod and lot number was visually inspected and found to have no damages or anomalies, specifically on the venous (blood) inlet port.All oxygenators are 100% visually inspected at several points in the production process.The packaging of the product also ensures protection against damage to the ports.It is likely that the port was damaged by a shock force at some point during the handling of the product; however, when or how this shock force was applied was not able to be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX25RWC W/ RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6994848
• MDR Text Key: 91224192
• Report Number: 1124841-2017-00228
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2017

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: 06/30/2020
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: VH17
• Other Device ID Number: (01)00699753450837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/01/2017
• Supplement Dates Manufacturer Received: 10/27/2017; 12/12/2017
• Supplement Dates FDA Received: 11/15/2017; 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2017
• 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