MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RWC

Device Problem Use of Device Problem (1670)

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

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, 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.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator was not able to transfer an efficient amount of gas.At one point, there was an increase of ~730 rpms to maintain the same 5.6 lpm blood flow rate.The pco2 values started to increase and the po2 values started to decrease resulting in the need for 100% fio2 and 15 lpm gas flow.The act values kept decreasing despite numerous additional doses of heparin being administered during cpb.The act values responded to the heparin administration initially but then began to deteriorate.The act values decreased to 439, 474 and 457 during cpb.No health consequences or impact to patient.The product was changed out.The surgery was completed successfully.

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: d1 (suspected medical device - corrected brand name).D4 (additional device information - corrected unique identifier (udi) number).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 correction, additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 11 3331, 213, 67).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: 67 - no problem detected.The sample was visually inspected and did not find any anomaly including a breakage that could lead to gas transfer failure.The amount of oxygen transfer and carbon dioxide were measured according to the product inspection procedure manual.It was confirmed to meet the factory 's specifications and no anomaly was found in the gas performance.Review of the manufacturing record and the incoming inspection record of the actual sample confirmed that there was no anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on may 19, 2021.Upon further investigation of the reported event, the following information is new and/or changed: 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 FX25RWC 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: 11847914
• MDR Text Key: 252018460
• Report Number: 1124841-2021-00116
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450479
• UDI-Public: (01)00699753450479
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: ZA11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 110