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

Model Number 46402

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The service repair technician (srt) reported that during routine testing of the device at the service center, the roller pump indicator dial's silk screen was worn off.There was no patient involvement.

• Brand Name: TERUMO PERFUSION SYSTEM 8000
• Type of Device: 8K (PUMP, ROLLER TYPE)
• 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: 4651148
• MDR Text Key: 5617760
• Report Number: 1828100-2015-00271
• 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: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 46402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2015
• 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