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

Model Number 16402

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the occlusion knob on the roller pump was jerky.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.Per the clinical review on (b)(6) 2014: the user facility's biomedical engineer (biomed) was called to the operation room (or) to observe the behaviour of the roller pump.The biomed stated the pump was being used for suction and continued to function.The roller assembly, as it rotated, would hesitate at slow speeds in a pulsatile type manner.The pump continued to work, but had a "jerky" pattern.Towards the end of pb, when the need for suction diminished, the perfusionist (ccp) took the tubing from this pump and moved over to an adjacent back-up pump on the base.After the procedure, the roller pump was removed form the base.The procedure was completed successfully, without delay and without associated blood loss.There was no harm observed or reported.

Manufacturer Narrative

The user facility's biomedical engineer (biomed) was not able to duplicate the complaint.The perfusionist (ccp) stated she may have had the unit over occluded.The biomed is trained by the manufacturer and will be performing a preventative maintenance (pm) on the roller pump to assure the unit works correctly.

• 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: 4138609
• MDR Text Key: 22140838
• Report Number: 1828100-2014-00793
• 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: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• 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: 09/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2003
• 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