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

Model Number 3ZZ*FX25RECA

Device Problem Use of Device Problem (1670)

Patient Problem Blood Loss (2597)

Event Date 12/18/2019

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.For this reason, terumo references evaluation conclusion code 11.(b)(6).(b)(4).Results: 3233-results pending completion of investigation.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the co2 was unable to be blown off.The patient was being cooled to 18 degrees celsius.The oxygenation was fine, however, the co2 continued to increase.The oxygenator was changed out during the planned circulatory arrest.*minor blood loss due to the patient being hemodiluted per the circulatory arrest case *product was changed out *procedure completed sucessfully.

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); 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 actual sample was visually inspected and found no breakage or other obvious anomaly that could lead to the poor gas transfer performance.After having been rinsed and dried, it was measured for its o2 transfer and co2 removal performance in accordance with the factory's shipping inspection protocol.No anomalies were revealed in the gas transfer performance of the actual sample.The investigation result verified that the actual sample was the normal product with no issue in the gas transfer performance.A review of device history record and incoming inspection record of the involved product/lot number combination confirmed that there were not any indications of anomaly in them.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Additional information has been received from the user facility.The patient had aortic insufficiency, a bicuspid aortic valve, and aortic root dilatation.The patient was immediately cooled to 18 degrees celsius in preparation for circulatory arrest.The pco2 began to rise so the sweep was adjusted to accommodate; however, it kept rising.The co2 was flowing at approximately 1.5 lpm.Flows were decreased and the recirculation line was opened, this only helped somewhat.All gas lines were checked, adequate gas flow was going to the oxygenator.Occasionally, the po2 would rise into the upper 70s.Since the patient was cold for quite some time, it was decided to change out the oxygenator.There was a delay of 4 minutes as the new oxygenator was primed, de-aired and began the retograde cerebral perfusion.Once the oxygenator was changed, pco2 was difficult to manage until the patient reached approximately 34 degrees celsius.The pco2 was in the 60s and 70s a various times.The numbers were verified with blood samples.

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 january 8 2020.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: NS 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: 9566340
• MDR Text Key: 193907813
• Report Number: 1124841-2020-00006
• Device Sequence Number: 1
• Product Code: DTZ
• 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: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 3ZZ*FX25RECA
• Device Catalogue Number: N/A
• Device Lot Number: XL30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 120