MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX15RE OX W/ 4L RES

Model Number 3CX*FX15RE40

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 06/16/2015

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems corporation that during cardiopulmonary bypass, a clot was noted in the reservoir two (2) hours after being on the pump.The device was not changed out since extra heparin was administered, and the procedure was completed successfully without delay.No known impact or consequence to patient.Product was not changed out.Surgery was completed successfully without delay.

Manufacturer Narrative

Terumo has received the actual device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and more information becomes available.(b)(4).

Manufacturer Narrative

This follow-up report is submitted to the fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on july 9, 2015.(b)(4) upon completion of the investigation, the event could not be confirmed.The actual sample was visually inspected and no anomalies were observed with the reservoir assembly or filters.The reservoir was tested for clotting by circulating bovine blood (hct=32.6%) through the reservoir vr filter at 7 l/min for 1 hour.No issues were observed during circulation.The blood was drained and the filter was inspected.No clotting was observed.Deionized water was circulated through the reservoir to rinse it.No clotting was observed after rinsing.Additional information obtained from the user facility revealed that the patient had a mitral valve replacement in 2005 and subsequently was exposed to heparin.It is possible that the event was caused by heparin resistance/sensitivity phenomenon.A review of the device history record revealed no anomalies.Since the actual sample passed the reservoir clotting test, the root cause has been attributed to the patient's blood condition(s) and/or the perfusionist's management of act.Method - actual device evaluated.Method - visual inspection.Method - hematologic testing.Results - no failure detected.Conclusions - unable to confirm complaint.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: STERILE FX15RE OX W/ 4L RES
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: robyn o'donnell, quality manage ; 125 blue ball rd.; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4921984
• MDR Text Key: 6056094
• Report Number: 1124841-2015-00200
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor,distributor,fo
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2015

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: 07/31/2017
• Device Model Number: 3CX*FX15RE40
• Device Lot Number: RK25
• Other Device ID Number: (01)00699753450455
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 10 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 07/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2014
• 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: 63 YR
• Patient Weight: 56