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

Model Number 3CX*FX25REC

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2021

Event Type  Injury  

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 Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, they were unable to remove co2 but oxygen transfer seemed normal.The case was a circulatory arrest procedure.Blood loss 350 cc.Product was changed out.Procedure was completed successfully.

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 march 19, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4: (additional device information - added lot number).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.

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: h6 (identification of evaluation codes 10, 11, 3331, 213, 4315).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 4315 - cause not established.Visual inspection of the actual sample upon receipt did not find any anomaly including a breakage that could lead to gas transfer failure.After rinsing and drying the actual sample, the amount of oxygen transfer and carbon dioxide gas removal were measured according to the product inspection procedure manual and was confirmed to meet factory's specification and no anomaly was found in the gas transfer performance.Review of the manufacturing records and the incoming inspection record of the actual sample confirmed that there was no anomaly in them.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX25REC W/RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 11526271
• MDR Text Key: 240955242
• Report Number: 1124841-2021-00063
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820
• Combination Product (y/n): N
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: YP21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 03/22/2021; 05/04/2021
• Supplement Dates FDA Received: 04/09/2021; 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other