MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW30C

Device Problem Break (1069)

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

Event Date 10/17/2023

Event Type  malfunction  

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: 4739 - gas exchanger health effect - impact code: 2645 - no patient involvement, health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 1069 - break investigation findings: 3233 - results pending completion of investigation conclusions: 11 - conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular that during out of box, a broken recirc line was noticed.*no patient involvement.

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 november 7, 2023.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 3259, 4307).The affected sample was inspected upon receipt.The female l-shaped connector, at the end of the purge line, was confirmed to be broken.A representative retention sample was obtained and visually inspected, no damage was noted to the device.All capiox units are 100% visually inspected at several points in the production and packaging processes.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Broken recirc line.

• Brand Name: STERILE FX15RWC W/ 3L RES
• Type of Device: BLOOD GAS OXYGENATOR
• 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: 18087677
• MDR Text Key: 327563974
• Report Number: 1124841-2023-00256
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450783
• UDI-Public: (01)00699753450783
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

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*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: 3F22
• 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: 10/17/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• 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