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 07/03/2018

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 setup, when the shunt sensor was being unpacked, a leak was found.No patient involvement as this occurred during setup; 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 july 30, 2018.(b)(4).Upon completion of the investigation, the event is confirmed.The sample was visually inspected, there was no buffer solution in the device.No other visual anomalies were noted.The unit was pressurized with air up to 1030 mmhg, submerged in a water bath, no leaks were noted within the device.The large blue cap was then loosened and retightened with a calibrated torque wrench to production specification.The unit was then pressurized with air, submerged in a water bath, a leak was noted from the large blue luer cap at approximately 220 mmhg.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.The retention sample was then pressurized with air, submerged in a water bath, a leak was noted at approximately 700 mmhg.The cap was loosened and retightened with a calibrated torque wrench to production specification.The unit was then pressurized with air, submerged in a water bath, a leak was noted from the large blue luer cap at approximately 550 mmhg.The complaint was confirmed and the root cause for this event is a lack of sealing between the large bore adapter 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.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: 7732643
• MDR Text Key: 115473137
• Report Number: 1124841-2018-00165
• 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: 08/23/2018

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: 12/31/2018
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: WA15A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 08/06/2018
• Supplement Dates FDA Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1