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 Blood Loss (2597)

Event Date 08/23/2019

Event Type  Injury  

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 Description

The user facility reported to terumo cardiovascular that during use in an extracorporeal membrane oxygenation (ecmo) circuit leakage from the cuvette was observed.The circuit was suspended in order to replace the cuvette with a backup cuvette to continue the procedure.However, leakage was observed again when the probe was connected to the cuvette.When the probe was detached from the cuvette, leakage stopped.The manufacturer was provided with the information that the patient was an infant, but no demographics were provided.There was less than 30ml blood loss.Product was changed out.Procedure was completed successfully.

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 september 13, 2019.The returned sample was visually inspected for damage in the weld or barb area, no damage or visual anomalies were found that would be indicative of a leak; however, a slow leak was detected in the part when evaluated.The unit was then pressurized to 15.0 psi with air and submerged in a water bath to detect any possible leaks.A leak from the weld was observed at approximately 15.0 psi after holding about 3 minutes.A retention sample from the same product code and lot number was evaluated using 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.A sample size from each finished product lot is evaluated to ensure the product meets tcvs requirements for mechanical integrity.The leak was likely caused by an inadequate weld from the welding process that was so small and slow, it was not caught during the leak testing process.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
• MDR Report Key: 9050153
• MDR Text Key: 161170174
• Report Number: 1124841-2019-00257
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00699753270138
• UDI-Public: (01)00699753270138
• Combination Product (y/n): N
• PMA/PMN Number: K915265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: CV-6914
• Device Catalogue Number: N/A
• Device Lot Number: WL03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other