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

Model Number	CV-6913
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Injury (2348); Blood Loss (2597)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Additional 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.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, a blood leak was noted.Per user facility the cuvette was set to a cdi probe.When about one hour passed after the procedure started, blood leakage from the cuvette was observed.After the cdi probe was removed, a transparent tape was used to fix it.After that, no blood leakage or suction of bubbles was observed, and the procedure was continued.Percutaneous cardiopulmonary support (pcps) was used in the cardiac catheterization laboratory.After the procedure, the patient was transferred to the icu, and then a cdi500 system was used.The patient expired at a later date, on (b)(6) 2020.
Additional 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 march 2, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes (10, 11, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331- analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The complaint sample was visually inspected for damage in the weld or barb area that would be indicative of a leak.The unit did not have any visual defects.The unit was then pressurized with air and submerged in a water bath to detect any possible leaks.It was pressurized to 15 psi and did not leak.A retention sample from the same product code and lot number was evaluated sing the same test method; no visual damage on the weld or barb area and no leak when pressurized with air and submerged in a water bath was observed.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.

• Brand Name: H/S CUVETTE 3/8X3/8-JAPAN
• Common Device Name: BLOOD GAS MONITOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9776695
• Report Number: 1124841-2020-00048
• Device Sequence Number: 19456862
• Product Code: DRY
• UDI-Device Identifier: 00699753270121
• UDI-Public: (01)00699753270121
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K915265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: CV-6913
• Device Catalogue Number: N/A
• Device Lot Number: XC11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other