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 09/05/2019

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 bpm was removed from the calibrator, the shunt sensor was more wet than usual.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 27, 2019.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The returned sample was visually inspected upon receipt with no noted anomalies on the shunt body or sparger assemblies.It was noted that the unit did not have any buffer solution in it.New buffer solution was added.The unit was then set up for gas calibration with the cdi 500 and cdi 540.Gas calibration was attempted but failed with a co2 sensor air equilibrium error on pco2.Gas calibration was attempted again, and the unit was successful on the second attempt.The bpm unit was then taken out of the calibrator with the large bore cap still loosened to recreate the reported event.The unit and calibrator were wet and there was little to no buffer left in the unit.The large bore cap was hand tightened and the unit was then leak tested by connecting with the calibrated manometer, submerged into a water bath, and pressurized with air up to 1030 mmhg, and observed for any leaks.No leaks were noted.The retention sample from the same product code and lot number was found to be successfully gas calibrated and leak tested with no issues.The returned sample was found to be wet upon removing the bpm from the calibrator without tightening the large bore cap during the investigation.The most likely root cause is that the large bore cap had not been tightened prior to removing the bpm from the calibrator during use.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: 9131087
• MDR Text Key: 160529829
• Report Number: 1124841-2019-00267
• 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: 10/31/2019

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: 03/31/2020
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: XE22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1