MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NON-STER X-COATED SX25 W/ RES; BLOOD GAS MONITOR

Model Number 3ZZSX25RX

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has not 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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during set up, it was noticed that the female connection of the sampling line was frayed or broken.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 fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on october 25, 2016.Upon further investigation of the reported event, the following information is new and/or changed: (device availability), (date received by manufacturer), (indication that this is a follow-up report), (follow-up due to additional information), (device evaluation anticipated).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references (b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

The sample was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.The returned sample was visually inspected, and it was found that the luer had been damaged and deformed.A pigtail from a retention sample was obtained.The cap was removed, and the luer was dipped into cyclohexanone.The cap was then reattached and the sample was left to sit overnight.The cap was then removed and the luer was deformed or damaged in a similar fashion to the returned sample.A retention sample from the same product code/lot number combination was visually inspected and the pigtail was confirmed to not be damaged as the returned sample had been.It is likely that during the assembly of the pigtail, a bonding agent had come into contact with the luer or cap, and then the cap had been assembled onto the luer, and this caused the deformation of the luer.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: NON-STER X-COATED SX25 W/ RES
• Type of Device: BLOOD GAS MONITOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6055579
• MDR Text Key: 58358585
• Report Number: 1124841-2016-00364
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

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: 06/30/2019
• Device Model Number: 3ZZSX25RX
• Device Catalogue Number: N/A
• Device Lot Number: UH25
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 10/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/15/2016; 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2016
• 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