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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2021

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.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, when the shunt sensor was attached to the bpm on the artery side, leakage was observed at the part where the shunt sensor was connected.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 may 11, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information and device evaluation) h3 (device evaluated by manufacturer) h4 (device manufacture date) h6 (identification of evaluation codes 10, 11, 3331, 4210, 19) type of investigation code#1: 10 - testing of actual/suspected device type of investigation code #2: 11 - testing of device from same lot/batch retained by manufacturer type of investigation code #3: 3331 - analysis of production records investigation findings: 4210 - leakage/seal investigation conclusions: 19 - cause traced to user the returned sample was visually inspected.The sample was returned without the sparger assembly and with buffer in the unit.The returned 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.A bpm head was then attached to the sample.The sample was then leak tested a second time by connecting with the calibrated manometer, submerged into a water bath, and pressurized and leaks were noted around 644 mmhg.The large bore adapter blue cap was then loosened and re-tightened by hand.The bpm head was reattached.The sample was then leak tested a third time by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg, and no leaks were noted.A sample from the same lot number was visually inspected and confirmed to have no traces of buffer on the outside of the unit.The sample was then pressurized with air up to 1030 mmhg, submerged in a water bath, and observed for any leaks.No leaks were noted on the representative sample.A bpm head was then attached to the sample.The sample was then leak tested a second time by connecting with the calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg, and no leaks were noted.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: 11806593
• MDR Text Key: 251987039
• Report Number: 1124841-2021-00107
• 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: 06/22/2021

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: 12/31/2021
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: ZA04E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 06/21/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1