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

Model Number 3ZZ*FX25RECA

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 05/12/2021

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, the oxygenator clotted in the sock of the reservoir.As per the clinical specialist, an information was provided by the chief of perfusionist stating that, during the pre-bypass phase of the procedure, recirculating volume was noted in the cardiotomy filter area of the venous reservoir.The perfusionist performing the procedure called the chief perfusionist into his room to consult on the situation.The filtration media was challenged by adding additional crystalloid via the rapid prime port.It was observed that the additional prime volume added to the circuit was not flowing into the venous reservoir at an expected rate of flow.This indicated to the team that the depth media was occluded.The product had to be changed out.No impact to procedure or patient.This occurred after the pump suctions were initiated and blood was entrained from the field.According to the chief of perfusionist, the surgeons are always pressuring the perfusion team to initiate the pump suctions to recover the blood loss created during cannulation.He also stated that the act¿s were probably on the lower edge of acceptability.The actual act value is unknown.The product was changed out.There was a minimal blood loss.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 june 1, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp 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, 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 affected sample was inspected upon receipt with no significant visual anomalies.Blood was in the unit and was slightly clotted; most likely due to the time between the event and receipt.The affected sample and a representative retention sample from the same lot number was obtained with no visual anomalies noted on the retention sample.The samples were tested for clotting with bovine blood (hct 34.1%, be -0.8 and 37.1*c) at 5 l/minute for one hour with 100ml/min air injection.There was no clotting on the filter observed in the cardiotomy portion of the reservoir.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: 11913102
• MDR Text Key: 260481201
• Report Number: 1124841-2021-00125
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 3ZZ*FX25RECA
• Device Catalogue Number: N/A
• Device Lot Number: YL14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1