MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. NS FX RES ONLY; BLOOD GAS OXYGENATOR

Model Number 3ZZ*R4000C

Device Problem Circuit Failure (1089)

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

Event Date 12/30/2016

Event Type  Injury  

Manufacturer Narrative

Terumo has received the actual device; however, the investigation has yet to be completed.Terumo plans on submitting a follow up report when the investigation is complete and more information becomes available.(b)(4).Results pending completion of evaluation.

Event Description

The customer reported to terumo cardiovascular that during cardiopulmonary bypass, there was a circuit issue of forward flow.Perfusionist initiated hand cranking then changed the circuit.The patient was 100% responsive post surgery.There was a delay of two (2) minutes, there was a blood loss of at least 200ml, product was changed out, procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on january 27, 2017.(b)(4).The returned sample was visually inspected, during which no anomalies were noted, only dried blood could be seen within the cr filter.The reservoir sample was then set up in a circuit of bovine blood, and reservoir clotting testing was performed by circulating the blood through the cr filter for one hour.At completion of the hour, the bovine blood was flushed from the sample with saline solution and it was visually inspected.No anomalies were noted functionally during the one hour test, specifically with the flow through the reservoir.There were also no anomalies visually noted after completion of the test.A review of the device history record revealed no manufacturing anomalies.The reported event was not able to be replicated; therefore, the complaint was not confirmed and a definitive root cause was not able to be determined.Through communication with the customer contact, it is believed that the cause of the event is due to perfusionist error, and it is not believed that there are any functional issue with the terumo devices.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: NS FX RES ONLY
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6282369
• MDR Text Key: 65910588
• Report Number: 1124841-2017-00008
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 3ZZ*R4000C
• Device Catalogue Number: N/A
• Device Lot Number: UM24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• 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
• Patient Outcome(s): Other