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

Model Number	CV-6914
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Additional 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: 4765- cuvette.Health effect ¿ impact code: 4614 - serious injury/illness/impairment.Health effect ¿ clinical code: 4582- no clinical signs, symptoms or conditions.Medical device problem code: 1354- leak/splash.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.
Event or Problem Description
The user facility reported to terumo cardiovascular during cardiopulmonary bypass, 10 minutes after the pumping started, blood leakage was observed form the cuvette connected to a cardiopulmonary circuit (open heart surgery).There was an unknown amount of blood loss and is considered as serious injury on a pediatric case.Terumo continues to attempt to gain more information regarding this event from the user facility.A straight connector was connected to the circuit to continue the surgery.There was no delay, the product was changed out, and the procedure was completed successfully with no patient effect.
Event or Problem Description
Leakage.
Additional 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) h4 (device manufacture date) 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, and no anomalies were noted.The unit was pressurized to 15.0 psi +/- 1, with air and submerged in a water bath.No leaks were detected after about 3 minutes.The unit was then over pressurized to 20.0 psi and submerged in a water bath, in attempt to locate any slow leaks.No leaks were detected after about 3 minutes.The h/sat probe was attached to the unit and pressurized again to 15.0 psi with air and submerged in a water bath for 30 seconds, and a leak was noted immediately.A retention sample from the same product code and lot number was previously evaluated using the same test method; no visual damage 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.
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 may 24, 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.
Event or Problem Description
Leakage.

• Brand Name: H/S CUVETTE 1/4X1/4-JAPAN
• Common Device Name: 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: 16995480
• Report Number: 1124841-2023-00126
• Device Sequence Number: 19677251
• Product Code: DRY
• UDI-Device Identifier: 00699753270138
• UDI-Public: (01)00699753270138
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K915265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2023

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 06/22/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/21/2023; 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown