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

Model Number 3CX*FX25REC

Device Problem Infusion or Flow Problem (2964)

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

Event Date 06/12/2021

Event Type  malfunction  

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 noticed a reduced oxygenation performance.As per subsidiary, "the perfusion was performed with hypothermia at 32°c.Act after 33,250 iu heparin bolus, before ecc onset at 475 sec.Act 15 min after ecc start at 396 sec.; then heparin administration of 15,000 iu.Subsequent act control > 1000 sec.Approx.40 minutes after the start of the ecc (around 13:00), first occurrence of reduced oxygenation performance measured due to decreasing po2 with constant pco2, without any abnormalities in the pressure difference attributable to the oxy.Increase in fio2 with constant gas flow.Around 13:20 po2 continued to fall with a simultaneously increased fio2 and gas flow.Approx.At 13:26 clearly falling saturation values in the nirs (regional oximetry of the head).Nonin: fell below 10% of the baseline cdi: po2 increased from 7x to 9x with each increase in the gas values increase of the gas flow to 10l/min and fio2 100% no abnormalities with pressure difference of the oxy or blood flow rate.Decision to exchange oxy by changing the complete hlm.New machine brought into the surgery room both machines aligned to swap gas settings of the new machine to 100% and 8 liters electricity and gas of the new machine connected.Standstill announced, running machine stopped at 13:28:00 vein and artery clamped venous tubing repositioned arterial tubing repositioned and vented exchange of data transfer to the jocap computer (maquet) blood volume of the old machine moved into the new machine via the hemofilter.The interruption of the circulation lasts approx.2 minutes at a body temperature of 32°c.Immediate normalization of the saturation values in the patient, once the ecc was resumed with a new hlm.No known impact or consequence to patient.Product was changed out.Procedure 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: 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 additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 3331, 213, 67).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The affected sample was inspected upon receipt with no visual anomalies 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.It was confirmed to meet the factory's specification and no anomaly was found in the gas transfer performance.Review of the manufacturing record and the incoming inspection records of the actual sample show no anomaly in them.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 july 6, 2021.Upon further investigation of the reported event.The following information is new and/or changed: d1: (corrected brand name).D4: (additional device information, corrected model number and udi 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 correction and 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 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: 12124163
• MDR Text Key: 260451124
• Report Number: 1124841-2021-00164
• 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
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: YF04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 95