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 08/20/2018

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

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, a leakage was found from the shunt sensor.No patient involvement.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 september 7, 2018.(b)(4).The returned sample was visually inspected with no anomalies noted.The unit was then pressurized with air (as received) up to 1030 mmhg, submerged in a water bath, and no leak were noted.The large blue cap was then loosened and retightened with a calibrated torque wrench to production specification, it was then pressurized with the air, submerged in a water bath.No leak was noted.A retention sample from the same lot number was visually inspected and confirmed to have no traces of buffer on the outside of the unit or inside the pouch.It was then leak tested, pressurized up to 1030 mmhg.A leak was observed from the large bore cap after approximately 5 seconds.The root cause for the retention sample leak is a lack of sealing between the large bore adapter (blue cap) and the shunt sensor body.When the large blue vent cap is tightened, interference between the threads of the cap and the shunt sensor body exist, causing inadequate seal leading to a leak.However, the complaint was not confirmed, and a definitive root cause was not able to be determined.It is possible that the buffer solution was not completely wiped off the product after buffer fill during manufacturing.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
• MDR Report Key: 7857490
• MDR Text Key: 119651353
• Report Number: 1124841-2018-00221
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00699753160767
• UDI-Public: (01)00699753160767
• Combination Product (y/n): N
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: WE16C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1