MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SHUNT SENSOR SYS500; BLOOD GAS MONITOR

Model Number CDI510H

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2017

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.For this reason, terumo references (b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, there was a leak from the shunt sensor.No patient involvement as this occurred during prime.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 december 8, 2017.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.The returned sample was visually inspected.Some delamination noted on the chemistries caused by lack of buffer but no other defects were noted such as cracks or damages anywhere else on the device.No buffer and no caps were present upon receipt and the original packaging was not returned for evaluation.A known good cap was obtained and carefully attached to the large blue cap of the returned unit.The returned unit was pressurized with air to approximately 1043mmhg and submerged into the water bath for 30 seconds, no leaks were observed.The unit was removed from the water bath and an attempt was made to tighten the large blue luer cap, it was found to be fully tight and seated properly.It was pressurized again and placed into the water bath for 30 seconds, no leaks were observed.A retention sample from the same product code/lot number combination was visually inspected and confirmed to not have any buffer solution on the outside of the unit or within the pouch.It is possible that during the setup of the circuit, the connections made with the shunt sensor were not completely tightened or closed, causing them to leak.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: SHUNT SENSOR SYS500
• Type of Device: BLOOD GAS MONITOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7101079
• MDR Text Key: 95080290
• Report Number: 1124841-2017-00248
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2018

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: 05/31/2018
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: VG19A
• Other Device ID Number: (01)00699753160767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 12/11/2017; 01/16/2018
• Supplement Dates FDA Received: 01/03/2018; 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2017
• 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