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

Model Number	3CX*FX15RE30C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/11/2019
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 prime, a leak that came out of a tubing "pigtail" connected to the oxygenator.No patient involvement as this occurred during prime.Product was changed out.Procedure was completed successfully.
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 exp date).E1 (initial reporter - corrected last name).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to correction, additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes (10, 11, 3331, 3259, 25).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331- analysis of production records.Results code: 3259 - improper physical structure.Conclusions code: 25 - cause traced to manufacturing.The affected sample was inspected upon receipt noting a chemical void in the bonded connection.The sample was setup in a water circuit with minor occlusion to confirm the connection leaked.A representative retention sample was visually inspected with no signs of chemical voids in the bonded connections.The most likely cause is a poor bond during manufacturing.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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on nov 1, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d10 (date returned to manufacturer).G4 (date received by manufacturer).G7 (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.

• 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: 9268615
• Report Number: 1124841-2019-00299
• Device Sequence Number: 16705210
• Product Code: DTZ
• UDI-Device Identifier: 00699753450806
• UDI-Public: (01)00699753450806
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2019

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: 04/30/2022
• Device Model Number: 3CX*FX15RE30C
• Device Catalogue Number: N/A
• Device Lot Number: XF06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 11/13/2019; 12/03/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 11/26/2019; 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1