MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RWC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 12/04/2017

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.(b)(4).Results code: results pending completion of evaluation.Conclusion code: conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass procedure, the partial pressure of oxygen (po2) was very low.There was minimal blood loss.The product was changed out.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 december 20, 2017 all available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.The returned sample was visually inspected upon receipt and did not find any anomalies, such as break.After having been rinsed and dried, actual sample was tested for its gas transfer performance in accordance with the factory's shipping inspection protocol.No anomalies were revealed and the obtained values met the factory specifications.The investigation result was confirmed to be normal product with no issue in the gas transfer performance.A definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

When the sample was received for investigation, it was noted that the reported oxygentaor was not completely changed out.Another oxygenator unit was added and used in tandem.

• Brand Name: STERILE FX25RWC W/ RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7137066
• MDR Text Key: 95835869
• Report Number: 1124841-2017-00260
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: VL04
• Other Device ID Number: (01)00699753450837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2017
• 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