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

Model Number 16402

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem Not Applicable (3189)

Event Date 07/29/2014

Event Type  malfunction  

Event Description

The user facility's biomedical engineer (biomed) reported that during preventative maintenance (pm) of the device, the occlusion knob was stuck on the roller pump.The biomed broke the pump tongue while attempting to loosen the stuck occlusion.Since the event occurred during preventative maintenance, 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: 4096275
• MDR Text Key: 22265365
• Report Number: 1828100-2014-00707
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• 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: 07/29/2014
• 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