MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1

Model Number 802112

Device Problems Out-Of-Box Failure (2311); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2014

Event Type  malfunction  

Event Description

Upon receipt of the device, the customer request the field service representative (fsr) to install the pressure module.The pressure module would not configure.There was no patient involvement.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.The suspect pressure module was returned to the manufacturer for further evaluation.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4249828
• MDR Text Key: 16560234
• Report Number: 1828100-2014-00955
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/14/2014

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: Other
• Device Model Number: 802112
• Device Catalogue Number: 802112
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/24/2014
• Is the Reporter a Health Professional?: Unknown
• Initial Date Manufacturer Received: 10/14/2014
• Initial Date FDA Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1