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

Model Number 16402

Device Problem Fail-Safe Problem (2936)

Patient Problem No Patient Involvement (2645)

Event Date 01/14/2015

Event Type  malfunction  

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the roller pump control panel "stop" button does not work.There was no patient involvement.

• 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: 4494321
• MDR Text Key: 5569813
• Report Number: 1828100-2015-00059
• 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
• Report Date: 01/14/2015

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2015
• Initial Date FDA Received: 02/05/2015
• 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