MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW40C

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/24/2016

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 systems that after cardiopulmonary bypass, that white clots were observed at the oxygenator, post arterial filter.Once the cec stopped and one minute after the start of protamine, the white clots were observed.The remainder of the circuit was inspected, no clots were noted.The anticoagulation protocol was followed, suctions started 1.5 x act (instead of 2 times the act), act was 476 (instead of 500), heparin was given for act> 500.No known impact or consequence to patient.Product was not changed out due to the event occurring after cpb.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 may 12, 2016.Upon further investigation of the reported event, the following information is new and/or changed: (device availability), (date received by manufacturer), (indication that this is a follow-up report), (follow-up due to additional information), (device evaluation anticipated).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, (b)(4).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 systems in the initial report submitted.Method - actual device evaluated, photographic inspection, visual inspection, flow testing, manufacturing review.Results - no failure detected.Conclusions - no failure detected, device operated within specification.The device was returned for evaluation.Review of the device history records revealed no manufacturing issues.Photos of the white clots were provided from the customer, confirming the existence of the clots in the device.Visual inspection of the returned sample, confirmed a foreign matter substance.The sample was sent to the subassembly manufacturer for testing.The sample was built into a circuit where bovine blood was circulated at each flow rate to determine the pressure drop, the obtained values met all specifications.The bovine blood was then circulated for 6 hours, no anomalies were noted.The blood was removed and visually inspected, no blood clots were noted inside the device.Based on the visual inspection, this complaint is confirmed for the appearance of clots, but not confirmed for performance issues as it operated within specifications.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15RWC W/4L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 5651366
• MDR Text Key: 45097362
• Report Number: 1124841-2016-00193
• 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,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2016

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: 12/31/2018
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: UA11
• Other Device ID Number: (01)00699753450790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/01/2016; 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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