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

Model Number CDI510H

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2023

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.For this reason, terumo references evaluation conclusion code 11.Component code: 510- sensor.Health effect ¿ impact code: 2199- no health consequences or impact.Health effect ¿ clinical code: 4582- no clinical signs, symptoms or conditions.Medical device problem code: 1535- incorrect, inadequate or imprecise result or readings.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, during extracorporeal circulation the k+ value was not shown.As per the subsidiary, during extracorporeal circulation, only k+ value was not shown.The shunt sensor was changed out.A back up shunt sensor was used to continue the surgery, and the surgery completed successfully.The calibrated k+ values had already been entered, but the gas calibration had not been carried out.No consequence or health impact to patient.It is unknown whether there was a blood loss as a result if the reported issue.Product was changed out.Procedure was completed successfully.

Event Description

K+ value was not shown.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp 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, 3331, 213, 67).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The returned sample was visually inspected upon receipt with no anomalies noted.A new buffer solution was added to the returned unit, and was then gas calibrated using the cdi 500 and cdi 540.The affected sample was found to be successfully calibrated with no issues.Additionally, it was circulated with buffer solution and found to produce consistent values on the cdi500 monitor and was able to provide a consistent k+ reading.The failure mode seen by the customer could not be recreated; therefore, a definitive root cause could not be identified.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

K+ value was not shown.

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 17, 2023.Upon further investigation of the reported event, the following information is new and/or changed: d9 (device availability - added date returned to manufacturer).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H3 (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.).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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 16949918
• MDR Text Key: 315423168
• Report Number: 1124841-2023-00114
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00699753160767
• UDI-Public: (01)00699753160767
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2023

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 Expiration Date: 01/31/2024
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: 3C06D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 05/18/2023; 06/19/2023
• Supplement Dates FDA Received: 06/07/2023; 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1