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

Model Number 3ZZ*FX25RECA

Device Problem Improper Flow or Infusion (2954)

Patient Problem Blood Loss (2597)

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the actual device.Evaluation in progress.Terumo plans on submitting a follow-up report when the investigation is complete and more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass procedure, the perfusionist noticed blood bubbling out from the 1/4" blue capped port, the port located directly next to the 1/2" venous return port atop the capiox reservoir.The product was not changed out.There was a blood loss of (5) five to (10) ten cc.No known impact or consequence to patient.Procedure was completed successfully.

Manufacturer Narrative

The returned sample was visually inspected.It was found that there was a blue cap on venous inlet port of the reservoir that was not from a terumo product, but rather another manufacturer's cap that was connected to the port.No anomalies were noted anywhere on the device.The reservoir lid was then removed from the housing and a venous inlet port leak test was performed by clamping off the tubing connected and applying air pressure to the line.The port was pressurized to approximately 150 mmhg, which is the maximum pressure allowed in the reservoir.No leaks were noted during this test.The other manufacturer's cap had been left on the port during this 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.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: NS FX25REC W/RES
• 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: 6178634
• MDR Text Key: 62533186
• Report Number: 1124841-2016-00426
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2017

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: 07/31/2019
• Device Model Number: 3ZZ*FX25RECA
• Device Catalogue Number: N/A
• Device Lot Number: UK29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• 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