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

Model Number 3ZZ*FX25RECA

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation.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.For this reason, terumo references evaluation (b)(4).

Event Description

It was reported to terumo cardiovascular that during cardiopulmonary bypass, the fx oxygenator had a leak from the arterial sampling port that is attached to the arterial outlet.There was a 5cc blood loss, product was not changed out, surgery completed successfully.

Manufacturer Narrative

The returned sample was visually inspected, during which no anomalies were noted.A review of the device history record revealed no manufacturing anomalies.The sample was then filled with water and pressurized to 600mmhg for a period of time, and then further pressurized to 1000mmhg.The line was found to not leak from the pigtail line, or any other component.Terumo was informed that bone wax was applied to the leaking location; however, during visual inspection, bone wax was not detected.If bone wax was present on the location of the leak, this may have prevented the sample from leaking during the investigation.The reported event was not able to be replicated 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: 6154718
• MDR Text Key: 61736530
• Report Number: 1124841-2016-00423
• 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: 01/12/2017

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: 08/31/2019
• Device Model Number: 3ZZ*FX25RECA
• Device Catalogue Number: N/A
• Device Lot Number: UL12
• 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: 11/28/2016
• Initial Date FDA Received: 12/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2016
• 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