MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORPORATION STERILE FX15RWC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW40C

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2018

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).

Event Description

The user facility reported to terumo cardiovascular that after cardiopulmonary bypass, there were white clots noted in the oxygenator fibers.*no patient involvement.

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 august 10, 2018.(b)(4).The actual device was not returned for evaluation.A review of the provided photographs found the presence of some substances which were likely to be white thrombus formation on the surface of the oxygenator filter; however, that is not able to be confirmed.There were no anomalies noted in the production related records of the involved product code/lot number combination.Without the returned device and no additional information, a root cause can not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15RWC W/ 4L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7773961
• MDR Text Key: 116866799
• Report Number: 1124841-2018-00180
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450790
• UDI-Public: (01)00699753450790
• Combination Product (y/n): N
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

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: 03/31/2021
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: WE30
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 09/14/2018
• Supplement Dates FDA Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1