MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP; OXYGENATOR, CARDIOPULMONARY BYPASS

Lot Number 504105A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 12/11/2014

Event Type  malfunction  

Event Description

The perfusionist was retrograde priming when he noticed particulate matter in the arterial line filter believed to be gnats.

• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP; 125 blue bell rd; elkton MD 21921
• MDR Report Key: 4379619
• MDR Text Key: 5260642
• Report Number: 4379619
• Device Sequence Number: 2
• Product Code: DTZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/12/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Lot Number: 504105A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2015
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS