MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION H/S CUVETTE 1/4X1/4-JAPAN; BLOOD GAS MONITOR

Model Number CV-6914

Device Problem Leak/Splash (1354)

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

Event Date 04/19/2022

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, blood began to leak from the side of the cuvette.Per facility, when the cuvette was not connected to the h/s probe, there was no blood leakage.The procedure was continued without connecting the cuvette to the h/s probe and successfully completed.The cuvette was incorporated in a cardiopulmonary circuit manufactured by technowood.The product was not change out.The surgery was completed successfully with unknown amount of blood loss.

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).

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.) h6 (identification of evaluation codes 10, 11, 3331, 3259, 4307).Type of investigation #1:10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3:3331 - analysis of production records.Investigation finding: 3259 - improper physical structure.Investigation conclusions: 4307 - cause traced to component failure.The returned sample was inspected upon receipt, no anomalies were noted.The unit was then pressurized for 30 seconds at 15 psi.With air and submerged in a water bath to detect any possible leaks.A leak was observed after the 30 seconds when the pressure dropped and bubbles were noted.A retention sample was inspected and found to have no visual abnormalities.The unit was then pressurized with air and submerged in a water bath to detect any possible leaks.The unit did not leak.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

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 31, 2022.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: H/S CUVETTE 1/4X1/4-JAPAN
• 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: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 14549782
• MDR Text Key: 300723387
• Report Number: 1124841-2022-00120
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00699753270138
• UDI-Public: (01)00699753270138
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915265
• 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: 07/29/2022

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: 10/31/2023
• Device Model Number: CV-6914
• Device Catalogue Number: N/A
• Device Lot Number: YN30
• 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: 05/12/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 07/06/2022; 07/28/2022
• Supplement Dates FDA Received: 07/22/2022; 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TECHNOWOOD CARDIOPULMONARY BYPASS UNIT