MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number	3CX*FX15RE40C
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
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 out of box, the customer opens the wrong oxygenator pack.Instead of receiving a fx25 the customer received a fx15re40.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 july 15, 2021.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.
Additional 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, 3331, 170, 4315).Type of investigation: #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation findings: 170 - manufacturing process problem identified.Investigation conclusions: 4315 - cause not established.The affected sample was inspected upon receipt to confirm a fx15 was inside of a fx25 package.It is unknown exactly when or how this event occurred.The most likely cause of this issue is handling after the units left tcv control as applicable part, label and serial number counts were found to be correct with the applicable finished work orders.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15REC W/ 4L RES
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 12177461
• Report Number: 1124841-2021-00172
• Device Sequence Number: 16549769
• Product Code: DTZ
• UDI-Device Identifier: 00699753450813
• UDI-Public: (01)00699753450813
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2021

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: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 3CX*FX15RE40C
• Device Catalogue Number: N/A
• Device Lot Number: YE27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 08/13/2021; 08/31/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/31/2021; 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1