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

Model Number 3CX*FX25REC

Device Problem Particulates (1451)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2018

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.No known impact or consequence to patient.Particulates.Results pending completion of evaluation.Conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that after cardiopulmonary bypass, particulates were seen upon flushing the reservoir and circuit with saline.No known impact or consequence 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 march 05, 2018.(b)(4).The actual sample was not returned but the provided pictures were reviewed.Some fatty tissues were noticed inside the reservoir.Without the returned device, a thorough investigation cannot be performed.The retention sample from the same product code/lot number was used for the blood clotting test.Bovine blood was ran through the venous reservoir for an hour at 7l/min, at the end of the test the sample was rinsed and dried; a visual inspection confirmed no clotting or residues with the reservoir.The reported event was unable to be replicated; therefore, a definitive root cause was not able to be determined.It is likely that patient conditions contributed to the formations of fatty tissue or biological material within the reservoir.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE 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: 7313776
• MDR Text Key: 101693003
• Report Number: 1124841-2018-00035
• 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,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: VM16
• Other Device ID Number: (01)00699753450820
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1