MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number	3CX*FX15RE30C
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
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.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during other - non clinical activity, there were excess items received with their shipment.No patient involvement.
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 31, 2022.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H6 (identification of evaluation codes 3331, 4114, 4246, 4308).Type of investigation #1: 3331 - analysis of production records.Type of investigation #2: 4114 - device not returned.Investigation findings: 4246 - transport/storage problem identified.Investigation conclusions: 4308 - cause traced to transport/storage.The investigation verified that incorrect product was shipped.An sncr was sent for this incident to the appropriate distribution center for further investigation.The root cause was the distribution center picked and sent incorrect product.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15REC W/ 3L RES
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 14549667
• Report Number: 1124841-2022-00119
• Device Sequence Number: 12013820
• Product Code: DTZ
• UDI-Device Identifier: 00699753450806
• UDI-Public: (01)00699753450806
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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
• Operator of Device: Other
• Device Expiration Date: 12/31/2024
• Device Model Number: 3CX*FX15RE30C
• Device Catalogue Number: N/A
• Device Lot Number: 2A17
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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
• Patient Sex: Unknown