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

Model Number 3CX*FX25REC

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 06/22/2018

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that at the end cardiopulmonary bypass, a clot was noticed on the walls of the venous reservoir, when filling the patient with volume.The patient was still at 19 degrees when the reservoir was clamped and changed out.There was a delay of less than one minute for change out.The act was 569 just prior to cpb and that few thousand more of heparin was given before full cpb.There was no blood loss since the extra volume that was given was able to be hemoconcentrated prior to change out.No known impact or consequence to patient.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 july 11, 2018.(b)(4).The actual sample was not returned for evaluation; therefore a definitive root cause could not be determined.A retention sample from the same product code and lot number combination was performance tested no anomalies found.Visual inspection was also conducted prior to the test, and no anomalies were noted.The root cause could not be determined in the investigation.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: 7678563
• MDR Text Key: 113757018
• Report Number: 1124841-2018-00136
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820
• 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: 09/07/2018

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 Expiration Date: 12/31/2020
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: WA29
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 09/06/2018
• Supplement Dates FDA Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1