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 09/16/2022

Event Type  Injury  

Event Description

The user facility reported to terumo cardiovascular during pre- cardiopulmonary bypass, 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.*there was no delay, the product was changed out, and the procedure was completed successfully with no patient effect.

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: (b)(6) - serious injury/ illness/ impairment health effect ¿ clinical code:(b)(6)- 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 Description

Leakage.

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.

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, 11, 3331, 4210, 25).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: 25 ¿ cause traced to manufacturing.The affected sample was visually inspected upon receipt with no anomalies noted.It was then pressurized to 15.0 psi +/- 1, with air and submerged in a water bath for 30 seconds, and a leak was noted immediately near the loop portion of the unit.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.

Event Description

Leakage.

• 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: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 16996667
• MDR Text Key: 315906745
• Report Number: 1124841-2023-00128
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00699753270138
• UDI-Public: (01)00699753270138
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 06/22/2023
• 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
• Patient Outcome(s): Other