MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW30C

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/04/2022

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, it was noticed that there was diluted blood came off from the fiber bundle to the external shell.They were on cardiopulmonary bypass for 162 minutes with no issues.However, when breaking down the circuit dilute blood came off from the fiber bundle to the external shell.The heparin bolus was given by anesthesia at 11:31 and cpb was initiated at 11:58 which equates to a 27-minute difference.Heparin concentration levels and acts were monitored throughout the case.Listed out below the act and [hep] in order as they appear on the patient record.Post heparin act at 11:38 = 489 and [hep] = 1.5 first sample upon initiation of cpb: act = 625, [hep] = 2.0.Act = 585, [hep] = 2.0.Act = 650.Act = 480, [hep] = 2.0.Post protamine act at 15:16 = 116 and [hep] = 0.0.Came off cpb at 14:40 and the circuit sat slowly circulating until around 17:00 as the surgeon was implanting pacemaker leads.Although not on cpb supporting the patient, the circuit sat for several more hours and would have been used close to the 6-hour maximum time allotted.No known impact or consequences to patient.The product was not changed out.The surgery 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 december 6, 2022.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) h4 (device manufacture date) h6 (identification of evaluation codes 3113, 4114, 4210, 4315) type of investigation: #1: 3331 - analysis of production records type of investigation #2: 4114 - device not returned investigation finding: 4210 - leakage/seal investigation conclusions: 4315 - cause not established the affected sample was not returned for evaluation; however, an image that was provided confirmed a red liquid found on the gas inlet.The manufacturing record and incoming inspection record of the actual product found no anomaly in three putative lot numbers.Since the product could be used without problems for 162 minutes after the start of circulation, it was inferred that the leakage was not coming from the fiber bundle but due to plasma leakage.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15RWC W/ 3L 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: 15927274
• MDR Text Key: 308096403
• Report Number: 1124841-2022-00180
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450783
• UDI-Public: (01)00699753450783
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: 2A31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 57 KG