MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PERFUSION SYSTEM 8000

Model Number 16402

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem Not Applicable (3189)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

The service repair tech (srt) reported that during routine testing of the device at the service ctr, bearing fluid contaminated the dual tach board and encoder wheel producing a "belt slip" error on the roller pump.There was no patient involvement.

Manufacturer Narrative

Eval is in progress, but not yet concluded.The bearing, drive belt and dual tach board will be replaced and returned for eval.

• Brand Name: TERUMO PERFUSION SYSTEM 8000
• 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: 3979785
• MDR Text Key: 4884208
• Report Number: 1828100-2014-00459
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953901
• 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

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: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2014
• Initial Date FDA Received: 06/04/2014
• 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