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

Model Number 16402

Device Problems Device Operates Differently Than Expected (2913); Pumping Problem (3016)

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

Event Date 02/11/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the belt broke on the arterial roller pump.There was a short delay (about three minutes) when they change the roller continue the surgery.As a result, an alternate device was employed.The surgical procedure was completed successfully, and there were no blood loss or no adverse consequences to the patient.Per clinical review on (b)(6) 2014: on (b)(6) 2014 at (b)(6) hospital in (b)(6), there was an issue with a sarns 8000 roller pump.In the first few minutes of cardiopulmonary bypass, prior to aortic cross-clamping and prior to cardioplegic arrest when the patient was still warm (normothermic), the roller pump (arterial) stopped without warning (no alerts or alarms).The roller assembly was not able to be re-started and the ccp began to hand crank the roller pump.Another roller pump (spare) was in the operating room and was used to back-up support.The ccp removed the tubing from the arterial pump and removed the original pump from the 8000 base.The spare pump was placed and connected in the same location on the base and the arterial tubing was placed in the roller pump.The roller occlusion was checked and cardiopulmonary bypass was re-started.Since the spare pump was in the operating room and readily available, the loss of arterial flow could reasonably be predicted to be about ninety seconds.The remainder of the procedure was without issue.The procedure was completed successfully, without associated blood loss.The delay could be estimated to be about three minutes and this allows for hand cranking, troubleshooting and pump change out.There was no harm of the patient observed or reported.According to the biomed at the hospital, a broken pump belt is suspected.

Manufacturer Narrative

The user facility's biomedical engineer (biomed) did not know what they did to complete the procedure, but all indications to him was that there was no patient injury.The biomed stated his (b)(6) was not that good.

• Brand Name: TERUMO PERFUSION SYSTEM 8000
• Type of Device: 8K (ROLLER PUMP)
• 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: 3831970
• MDR Text Key: 4500817
• Report Number: 1828100-2014-00140
• 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: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: Yes
• 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?: No
• Date Manufacturer Received: 02/12/2014
• 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
• Patient Outcome(s): Required Intervention