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

Model Number 3ZZ*FX25RECA

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2019

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. (b)(4).

Event Description

The user facility reported to terumo cardiovascular that after cardiopulmonary bypass, the oxygenator clotted.   as per the user facility, once the case was completed, the perfusionist tried to re-prime the circuit, and they noticed that the oxygenator clotted. Additional information was obtained by the clinical specialist that, the account indicated that even though the pump sucker(s) was turned off prior to protamine administration, the vents were still being utilized until 50% of the protamine was infused. Protamine is administered directly into the blood stream. If blood is being vented from the heart to the cardiotomy section of the reservoir during protamine administration clotting can occur in the cardiotomy filter. The procedure was completed successfully with no issues and oxygenator worked properly during the case. No patient involvement.

• Brand Name: NS FX25REC W/RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 8962471
• MDR Text Key: 159603565
• Report Number: 1124841-2019-00247
• 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: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2022
• Device Model Number: 3ZZ*FX25RECA
• Device Catalogue Number: N/A
• Device Lot Number: XE08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial