MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP TERUMO PERFUSION SYSTEM 8000; 8K (PUMP, ROLLER TYPE)

Model Number 16402

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/19/2014

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the roller pump displayed a "reset" message and would not turn on.As a result, an alternate device was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the pt.

Manufacturer Narrative

The field service representative (fsr) could not duplicate the reported issue.No parts will be returned to the manufacturer for evaluation.The fsr performed corrective maintenance/inspection which was completed successfully.The unit operated to manufacturer specifications and was returned to clinical use.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: TERUMO PERFUSION SYSTEM 8000
• Type of Device: 8K (PUMP, ROLLER TYPE)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3987592
• MDR Text Key: 19298807
• Report Number: 1828100-2014-00470
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2011
• 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