MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SX OXYGENATOR W/ HR X COATING; BLOOD GAS OXYGENATOR

Model Number 3CXSX25R

Device Problem Pressure Problem (3012)

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has 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.For this reason.(b)(4).Results - results pending completion of evaluation.Conclusions - conclusion not yet available-evaluation in progress.

Event Description

It was reported to terumo cardiovascular that during pre cardiopulmonary bypass, the oxygenator was not holding pressure.There was no patient involvement.Product was changed out.The surgery was completed successfully.

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 december 8, 2016.(b)(4).The sample was returned for evaluation.The sample was visually inspected, during which no anomalies were noted.During the decontamination process, bleach solution and water were circulated through the device.It was found that the fluid leaked through the gas ports during this circulation.No pressure was applied to the device during this circulation.It was found that there was a leak in the pipes of the heat exchanger.A retention sample from the same product code/lot number combination was obtained for evaluation.Visual inspection found no anomalies on the retention sample.The blood side of the unit was then filled with water and pressurized to approximately 650 mmhg.No leaks were noted from anywhere on the device, specifically through the gas ports.A review of the device history record revealed no manufacturing anomalies.All heat exchangers are leak tested in process; therefore, it is likely that damage occurred to the device at some point after manufacture that caused a pipe(s) in the heat exchanger to leak.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: SX OXYGENATOR W/ HR X COATING
• 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: 6156632
• MDR Text Key: 61887751
• Report Number: 1124841-2016-00425
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153140
• 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: 02/08/2017

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: 3CXSX25R
• Device Catalogue Number: N/A
• Device Lot Number: UK22
• Other Device ID Number: (01)00699753450073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2016
• 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