MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS STERILE FX25RW OXY W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RW

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 10/30/2015

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the actual 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/or when more information becomes available.No known impact or consequence to patient coagulation in device or device ingredient (b)(4).

Event Description

The user facility reported to terumo cardiovascular systems that during after completion of cardiopulmonary bypass, clot formation in the oxygenator and reservoir were observed.There was no case delay, no blood loss and no patient issues, as reported by the customer.No known impact or consequence to patient.The product was not changed out, as the event was seen after the procedure ended.The surgery was completed successfully without delay.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations and as indicated by terumo cardiovascular systems.Method: actual device evaluated.Device from reserve sample evaluated.No failure detected.Results- biological problem.Conclusions code: human factors issue.The actual sample was returned for evaluation.Visual inspection was performed on the sample upon receipt, and it was found that there were major biological clots within the reservoir and oxygenator.During the decontamination process, the clots were not able to be completely removed from the reservoir.A review of the device history records revealed no manufacturing issues.Two separate investigations were performed, one on the reservoir and one on the oxygenator.As the reservoir could not be completely decontaminated, functional testing was not able to be performed on the unit; therefore, a retention sample from product code 3cx*rx25rw lot tg15 was obtained for reservoir clot testing.This test consisted of bovine blood being circulated through the reservoir and an oxygenator sample for one hour.At the completion of the hour, the bovine blood was drained, the reservoir was rinsed, and visual inspection was performed to determine if any clots had formed in the device.It was confirmed that no clotting occurred and the device was normal product.The returned oxygenator sample was able to be tested by building it into a circuit and circulating bovine blood through the device.The pressure drop was determined at several flow rates, and it was confirmed that each obtained value met product specifications.At the completion of this test, the oxygenator sample was disassembled and confirmed to have no visual anomalies.A definitive root cause could not be determined; however, the complaint was confirmed based on the visual inspection noting several major clots within the returned device.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 - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on 11/19/2015.A second follow-up will be submitted upon completion of the investigation and/or submission of new information.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: STERILE FX25RW OXY W/ RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: robyn o'donnell ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5237990
• MDR Text Key: 31966457
• Report Number: 1124841-2015-00302
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2016

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: 05/31/2018
• Device Model Number: 3CX*FX25RW
• Device Lot Number: TG15
• Other Device ID Number: (01)00699753450479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 11/19/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/10/2015; 01/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2015
• 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: 41 YR
• Patient Weight: 108