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

Model Number 16402

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the roller pump was not providing suction.As a result, the perfusionist (ccp) changed out the one-way valve.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the pt.Per the clinical review on (b)(6) 2014: the report is that field suction was not adequate per the cardiovascular (cv) surgeon.The sarns 8000 suction roller pump was checked for proper collusion and it was adequate.The perfusionist (ccp) removed the medtronic disposable one-way pressure relief valve from the tubing assembly, and that corrected the issue.Suction was adequate the remainder of the procedure.This was not a mfr valve and there was no issue with the sarns roller pump.Though suction was not adequate for a period of time, the cv surgeon used the cell saver suction during troubleshooting and thus no delay in the surgical procedure.There appeared to be no malfunction issues with the roller pump.There was no associated blood loss and no harm was observed.

Manufacturer Narrative

This complaint is related to mdr # 1828100-2014-01108.Per the ccp, there was no pump jam or pump stop.The field service representative (fsr) checked the condition of bearings and rollers, all in excellent condition and free moving.The fsr checked the roller to roller setting which was within the 0.0015 limitation.As a precaution, the fsr swapped out serial number (b)(4) position one pump with serial number (b)(4) position four pump.Each pump performed to mfr specifications and was returned to clinical use.

• 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: 4366166
• MDR Text Key: 5288959
• Report Number: 1828100-2014-01109
• 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: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• 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: 12/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2007
• 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
• Treatment: AND TUBING PACK; MEDTRONIC DISPOSABLE ONE-WAY PRESSURE RELIEF VALVE