MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYS 1; APS 1 (HEART LUNG CONSOLE)

Model Number 801558

Device Problem Overheating of Device (1437)

Patient Problem Not Applicable (3189)

Event Date 03/10/2014

Event Type  malfunction  

Event Description

The product surveillance technician reported that during routine testing of the device at the service ctr, the lens melted on the lamp assembly of the perfusion sys.There was no pt involvement.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

• Brand Name: TERUMO ADVANCED PERFUSION SYS 1
• Type of Device: APS 1 (HEART LUNG CONSOLE)
• 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: 3818608
• MDR Text Key: 4502102
• Report Number: 1828100-2014-00254
• 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: 03/10/2014

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: 801558
• Device Catalogue Number: 801558
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/04/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1