MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SX OXYGENATOR W/HR (STERILE); BLOOD GAS OXYGENATOR

Model Number 3CXSX18R

Device Problem Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, 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 prior to cardiopulmonary bypass, during set up, a kink was found in the line where the manifold gets connected.*no patient involvement as this occurred during set up.*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 september 2, 2016 (b)(4).The sample was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.Visual inspection of the returned sample confirmed that the pigtail tubing was kinked.All capiox products are 100% visually inspected in process; therefore, it is likely that this tubing was not kinked until after packaged.Due to the curvature in the tubing, it is likely that the tubing was damaged by the way the product was placed and sat in its packaging for an extended period of time.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: SX OXYGENATOR W/HR (STERILE)
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 5925742
• MDR Text Key: 53908412
• Report Number: 1124841-2016-00317
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2016

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: 06/30/2018
• Device Model Number: 3CXSX18R
• Device Catalogue Number: N/A
• Device Lot Number: TH27
• Other Device ID Number: (01)00699753450035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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