MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25REC

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2023

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, a leakage at the arterial temperature interface was noticed.Per facility, samples were investigated by hmt and it was found that the affected temperature port of the oxygenator was not connected by hmt.No patient involvement.The product was changed out.The surgery was completed successfully.

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.H6: component code: 4761 - access port.Health effect - impact code: 2645 - no patient involvement.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.

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 expiration 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, 706, 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 finding: 706 - assembly problem identified.Investigation conclusions: 25 - cause traced to manufacturing.The affected sample was inspected upon receipt.It was noted that the arterial thermistor was not affixed to the oxygenator.However, there was bonding agent noted within the port.A representative retention sample was obtained and visually inspected.The arterial thermistor was bonded to the oxygenator appropriately.A training was conducted with the production associates to make them aware of this event and to ensure that all thermistors, and other components, are properly assembled and inspected on the reservoir and oxygenator.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Leakage at arterial temperature interface.

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 july 6,, 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 Description

Leakage at arterial temperature interface.

• Brand Name: STERILE FX25REC W/RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkotn MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 17266416
• MDR Text Key: 318614679
• Report Number: 1124841-2023-00166
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151791
• 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: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: 2F09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 06/30/2023; 08/01/2023
• Supplement Dates FDA Received: 07/21/2023; 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2022
• 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 Sex: Male