MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number	3CX*FX25REC
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
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 during cardiopulmonary bypass, the blood was dripping out of the fibre bundle and outlet port.At approximately 30 minutes after starting cardiopulmonary bypass, blood was noted to be dripping from the port/opening below the blood inlet.They were unsure where the blood was coming from, therefore, they placed some bone wax along some seams to look for changes.There was no change in the blood drip rate, and did not seem to be any failure of the oxygenator.There was no harm to patient; hence, the oxygenator was not changed out and a close monitoring was done for oxygenator failure and increase bleeding.There was a blood loss of less than 100 mls.The product was changed out.Procedure was completed successfully.
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.  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: g3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information ).H6 (identification of evaluation codes 4114, 3221, 4315).Type of investigation: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The affected sample was not returned for evaluation and the lot number was unknown.A sufficient investigation could not be carried out and the definitive cause could not be determined.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: e1: (initial reporter, updated establishment name).G3: (date received by manufacturer).G6: (indication that this is a follow-up report).H2: (follow-up, due to correction and additional information).A third 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 FX25REC W/RES
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 12177067
• Report Number: 1124841-2021-00170
• Device Sequence Number: 1622337
• Product Code: DTZ
• UDI-Device Identifier: 00699753450462
• UDI-Public: (01)00699753450462
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/29/2021

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 Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 08/03/2021; 09/03/2021; 09/24/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/26/2021; 09/20/2021; 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1