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

Model Number CDI510H

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 10/02/2018

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was a leakage of blood out of the dots on the shunt sensor.There is a few ml of blood loss.The product was changed out.Procedure 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 oct 19, 2018.(b)(4).The returned sample was visually inspected.The sparger assembly and white cap were not returned with the sample.Additionally, the large bore adapter blue cap was not seated fully on the device.The returned sample was then leak tested (as received) by connecting with the calibrated manometer, submerged into a water bath, and pressurized.A leak was noted at 9 mmhg.The large bore adapter blue cap was then loosened and re-tightened by hand.The sample was then leak tested by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg, and no leaks were noted.The first leak was most likely attributed to the loose cap, as received.A retention sample of the same product code and lot number combination was visually inspected, and no visual anomalies were noted.The retention sample was also leak tested up to 1030 mmhg, and no leaks were noted.The root cause for this event may have been the large blue vent cap for the shunt sensor was not fully tightened either during setup of the circuit, or after the gas calibration.When the large blue vent cap was loosened, it may not have been re-tightened fully prior to use in the line, causing 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: 7986646
• MDR Text Key: 124501800
• Report Number: 1124841-2018-00263
• 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: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• 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: WE23F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1