MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION H/S CUVETTE 3/8X3/8-JAPAN; BLOOD GAS MONITOR

Model Number CV-6913

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2022

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular during cardiopulmonary bypass, there was a blood leakage.It is unknown if there was a delay in the procedure, whether the product was changed out, or the surgery was completed successfully and if there was any effect on the patient or results of the surgery.Due to the unknown information for this event, it is being reported.Terumo continues to attempt to gain more information regarding this event from the user facility.Additionally, during auxiliary circulation, the circuit was replaced on july 10.The leakage from the cuvette was noted at the circuit on july 12.The surgeon was advised to replace the circuit, but it was unknown whether it was replaced during the circulation.There was an 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.For this reason, terumo references evaluation conclusion code 11.(b)(4).

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: h6 (identification of evaluation codes 10, 11, 3331, 4210, 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 findings: 4210 - leakage/seal; investigation conclusions: 4307 - cause traced to component failure.The returned sample was visually inspected upon receipt and noted to have a dried blood within the unit.The sample was pressurized to 15.0 psi +/- 1, with air submerged in a water bath for 30 seconds to detect any possible leaks.No leaks were noted.The h/sat probe was then attached to the unit and it was pressurized the same way, and no leaks were noted.A retention sample from the same product code and lot number was evaluated using the same test method; no visual damage and no leak when pressurized with air and submerged in a water bath was observed.Due to the state of the unit, it's likely that the blood within the unit had dried, creating a seal that prevented the unit from leaking during testing.H/s cuvettes are 100% leak tested and visually inspected in process to ensure each part meets tcvs specifications.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 august 12, 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 3/8X3/8-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: 15220331
• MDR Text Key: 305055855
• Report Number: 1124841-2022-00138
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00699753270121
• UDI-Public: (01)00699753270121
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: CV-6913
• Device Catalogue Number: N/A
• Device Lot Number: ZC08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2021
• 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