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

Model Number 16402

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the roller pump was contaminated.The 1/4 tubing (non-manufacturer) split and blood spilled into the raceway.The device was not changed out.Roller pump was used as the aortic vent pump.The surgical procedure was completed successfully.There were no delays, or no adverse consequences to the pt.Per clinical review on (b)(6) 2014: the perfusionist (ccp) was using a sarns 8000 perfusion system with a medtronic tubing pack and circuit.Later in cpb, after the aortic cross-clamp had been removed, the ccp noticed blood in the raceway of the roller pump that was being used for aortic venting.A 1/4" id tube was used in the pump and the ccp stated she had no issues with setting occlusion during preparation for the procedure.The ccp stopped the pump when she noticed the blood and venting was not needed for the remainder of cpb, so new tubing was not installed in the pump.After the case, the ccp inspected the roller pump for sharp edges or points on the rollers and she inspected the roller guides.No issues were found with the pump.The tubing was sent to medtronic for inspection and testing.The ccp reported this event to the roller pump manufacturer not due to concern that the roller assembly caused the fracture of the tubing, but that she had a concern that fluid ingress (from blood loss into the race) might cause an issue with the pump's function in following cases.The case was completed successfully, without delay.The ccp estimated the blood loss to be less than 25ml.There was no pt harm observed or reported.

Manufacturer Narrative

The surgeon had just finished with this section of the case and released the aortic cross clamp just prior to the split int he tubing occurring.Additional tubing was not needed as the pump was not required any longer at the porting of the procedure.There is no malfunction of the roller pump, the user would like to ensure no fluid ingress has contaminated the interior of the pump.The field service representative (fsr) cleaned the blood from under the rollers, delphin rollers and greased.He examined the casting which was smooth and clean.The unit operated to manufacturer specifications and was returned to clinical use.If additional information 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 (ROLLER PUMP)
• 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: 3832557
• MDR Text Key: 4403571
• Report Number: 1828100-2014-00242
• 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: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• 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: 03/06/2014
• 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: MEDTRONIC TUBING PACK