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

Model Number	3CX*FX15RE30C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/24/2020
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 there was a broken inlet line on the entrance to the oxygenator.Additionally, the perfusionist identified that this occurred because the box created pressure of the paper barrier in the package directly on this line.It is unknown when this event occurred, whether the product was changed out, or if there was any effect on the patient or results of the surgery.Terumo continues to attempt to gain more information regarding this event from the user facility.
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 september 11, 2020.G4 (date received by manufacturer).G7 (indication that this is a follow-up report).Additional information was received from the subsidiary regarding this event.It was determined that this event is not a malfunction of the actual device.The reported event was due to the repacking of the device at the subsidiary.There will be no additional follow ups submitted regarding this event.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
• MDR Report Key: 10521854
• Report Number: 1124841-2020-00219
• Device Sequence Number: 2720297
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

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 Model Number: 3CX*FX15RE30C
• Device Catalogue Number: N/A
• Device Lot Number: XP02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1