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

Model Number 3ZZ*FX25RECA

Device Problem Device Issue (2379)

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 09/20/2017

Event Type  Injury  

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 october 20, 2017. The actual sample was not returned so a thorough investigation of the reported event could not be performed. However, retention sample from same lot # venous reservoir filter was obtained. Visually inspected the retention sample, no anomalies were found. The sample was then connected to a circuit, and the reservoir clotting test was performed on the retention sample, which included circulating bovine blood through the unit for one hour at a high flow rate (7l/min). At the completion of the hour, the blood was drained and the unit was rinsed with di water. There were no clots located within the venous filter. The reported event was unable to be replicated; therefore, a definitive root cause was not able to be determined. It is likely that patient conditions contributed to the formations of clots within the reservoir filter. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

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 during cardiopulmonary bypass, an hour and 43 minutes into the procedure, the bubble alarm went off and a clot had formed inside the venous return sock on the cardiotomy reservoir. There was blood loss of 200 cc. There was a delay for 3 minutes. The product was changed out. Procedure was completed successfully.

• 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 Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6966130
• MDR Text Key: 249629843
• Report Number: 1124841-2017-00216
• 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,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2020
• Device Model Number: 3ZZ*FX25RECA
• Device Catalogue Number: N/A
• Device Lot Number: VF29
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/20/2017 Patient Sequence Number: 1