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.

• 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• 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
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

0 Patients were 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

• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial