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

Model Number 3CX*FX25RWC

Device Problem Infusion or Flow Problem (2964)

Patient Problems Cardiac Arrest (1762); Injury (2348); Blood Loss (2597)

Event Date 10/30/2019

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, there was an inadequate oxygenation and co2 elimination.As per the user facility, at the beginning of the perfusion, the po2 level at the rear of the oxygenator was only 90mmhg, pco2> 50mmhg at 3.3l gas flow and fio2 75%.In the course of the perfusion, fio2 and gas flow were further increased to 25 liters / fio2 100%.The po2 was between 67 and 102 mmhg, the pco2 between 43 and 55 mmhg.Approximately, after two hours of perfusion time an adequate oxygenation could not be maintained anymore, an additional oxygenator was integrated/connected in front of the defective oxygenator in the ecc (extracorporeal circulation) and there was a short cardiac arrest approximately for 100 seconds, due to the integration/connection.There was also a blood loss of less than 20 ml while cutting the tube.Afterwards, oxygenation and co2 elimination were adequate again.The product was not changed out.There was a delay for approximately 2 minutes.The procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulation.Upon further investigation of the reported event, the following information is new and/or changed: a1 (patient information - updated age).D4 (additional device information - updated lot number).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to 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.

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 november 22, 2019.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: d4 (additional device information - added exp date).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 11, 3331, 213, 67).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: 213 - no device problem found.Conclusions code: 67 - no problem detected.The returned sample was visually inspected upon receipt with no breaks or other anomalies that could lead to an inadequate gas transfer.After having been rinsed, the actual sample was tested for its gas transfer performance in accordance with the factory's shipping inspection protocol.No anomalies were revealed with the obtained values meeting the factory's specifications.The pump record involved were reviewed in this complaint.A review of the dhr and incoming inspection record of the involved product or lot number combination confirmed no indication of anomaly in them.The evaluation result verified that the actual sample after having been rinsed was the normal product with no issue in the gas transfer performance.From the available information, it is difficult to determine the definitive root cause.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: 9364973
• MDR Text Key: 168223770
• Report Number: 1124841-2019-00315
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: XC04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QUADROX-I-ADULT
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 75