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

Model Number 16402

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the perfusionist (ccp) stated the occlusion knob was stuck in fully open position on the roller pump.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) used spanner wrench to loosen the occlusion knob.The fsr removed the occlusion knob, checked for burrs on knob and threaded shaft, none were found.The fsr removed the old grease, re-greased and re-installed occlusion knob.The fsr performed corrective/preventative maintenance on the roller pump.The occlusion knob moved freely and the unit operated to mfr specifications and was returned to clinical use.No parts will be returned to the mfr for eval.If additional info 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 SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4114249
• MDR Text Key: 19589571
• Report Number: 1828100-2014-00749
• 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: 08/26/2014

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: Health Professional
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2005
• 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