MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX15RW OX W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW30

Device Problem Device Alarm System (1012)

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

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the actual device; therefore, 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).Conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass the bubble detector alarmed on their sorin s5 heart-lung machine.They did not find any air so they reset and went back on pump.Through the rest of the case they saw air activity being displayed on the heart-lung machine.Case was 1.5 to 2 hours long.Sensitivity was set to "medium".*no known impact or consequence to patient.*product was not changed out.*procedure completed successfully.

Manufacturer Narrative

A sample was not returned for evaluation and the lot number of the affected product was not provided; therefore, a complete investigation could not be performed and a definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15RW OX W/ 3L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6121807
• MDR Text Key: 60757328
• Report Number: 1124841-2016-00411
• Device Sequence Number: 1
• Product Code: DTZ
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX15RW30
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00699753450745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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