MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX25REC WRES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25REC

Device Problem Partial Blockage (1065)

Patient Problem Insufficient Information (4580)

Event Date 06/04/2016

Event Type  malfunction  

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).

Event Description

The user facility reported to terumo cardiovascular systems corporation that prior to cardiopulmonary bypass, during prime, the purge line was occluded.It was believed that the one way valve within the purge line was sealed.No known impact or consequence to patient.Product was not changed out.Surgery was completed successfully.

• Brand Name: STERILE FX25REC WRES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball rd.; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5614481
• MDR Text Key: 289194170
• Report Number: 1124841-2016-00122
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3CX*FX25REC
• Device Lot Number: UA18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: No
• 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