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

Model Number CDI510H

Device Problem Leak/Splash (1354)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

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 out of box, the product was leaking when opened.No patient involvement as this occurred during out of box.

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 december 18, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 510, 2645, 4582, 1354, 11, 3331, 4114, 3221, 4315) component code: 510 - sensor.Health effect - impact code: 2645 - no patient involvement.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 1354 - leak/splash.Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The sample was not returned for evaluation; therefore, a thorough investigation could not be performed.The reported unit / lot number was used almost a year past its expiration date.Date of use; november 24, 2020.Date of expire; november 30, 2019.The retention sample from the same lot number was previously inspected for another complaint ((b)(4)) 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 up to 1030 mmhg, submerged in a water bath, and observed for any leaks.No leaks were noted on the retention sample.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: 11040930
• MDR Text Key: 240753653
• Report Number: 1124841-2020-00284
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

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: 11/30/2019
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: WP10L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1