MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 MODULE PERFUSION SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM

Model Number 6379

Device Problem Device Sensing Problem (2917)

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

Event Date 07/02/2019

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the unit was displaying that there was still flow and back flow even if the pump was set to zero revolutions per minute (rpm) and the hoses were clamped.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The reported complaint was not verifiable.Multiple diligence attempts were unsuccessful for part return so no evaluation could be completed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

Updated block: b5.

Event Description

Per clinical review: on (b)(6) 2019, the unit was saying there was flow and backflow when the tubing was clamped and the revolutions per minute (rpms) were set to zero.The problem occurred was marked on bypass, but this cannot occurred during bypass.It is unknown of what the mitigation was, since there was no further information from customer.

• Brand Name: SARNS 8000 MODULE PERFUSION SYSTEM
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8813637
• MDR Text Key: 151893833
• Report Number: 1828100-2019-00398
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K915183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6379
• Device Catalogue Number: 6379
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1