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

Model Number 3ZZ*FX25RECA

Device Problems Use of Device Problem (1670); Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2020

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, the arterial temperature sensor didn¿t measure properly.Per user they could not exchange the temperature port because they were on bypass.They used the venous temperature for rewarming purposes.They hooked the wire to the venous sensor it worked fine.The product was not changed out.The surgery was completed successfully.No consequences or impact to patient.

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 21, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 3120, 2199, 4582, 3005, 11, 3331, 4114, 3221, 4315).Component code: 3120 - temperature sensor.Health effect - impact code: 2199 - no health consequences or impact.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 3005 - output problem.Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation findings:3221 - no findings available.Investigation conclusion: 4315 - cause not established.The affected sample was not returned so a thorough investigation could not be conducted.A representative retention sample was built into a water circuit with heated water flowing through the heat exchanger.Auxiliary thermometers were added immediately after the arterial outlet and immediately before the venous inlet.The difference between the auxiliary thermometers and the provided thermistors was negligible.Due to the device not being returned, the lack of information provided and the event not being duplicated with a retention sample, it is not possible to determine the exact cause this event.It is possible that the arterial thermistor was damaged in some way causing it to not read at all or correctly.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: 11048077
• MDR Text Key: 222813501
• Report Number: 1124841-2020-00285
• 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
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 3ZZ*FX25RECA
• Device Catalogue Number: N/A
• Device Lot Number: YK31
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1