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

Model Number 811474

Device Problem Decoupling (1145)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2020

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the centrifugal head became decoupled from the centrifugal motor.The end user noticed decoupling, reattached the centrifugal pump and the decoupling was resolved.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

Per clinical review: on march 13, 2020, during cardiopulmonary bypass (cpb), the perfusion team saw that the sp45 had decoupled from the drive motor on the heart lung machine (hlm).The system was set up and primed without issue for the procedure on (b)(6) 2020.The flow and revolutions per minute (rpm) during the procedure were appropriate, but the end user noticed during the cpb that the connection was not complete on the drive motor, as stated by the end user 'noticed the decoupling, then reattached the centrifugal pump'.It is not known what preceded the end user noticing the issue, but patient forward flow was consistent.The end user was able to recouple (properly attach) the centrifugal disposable to the drive motor without issue, and without a delay in the continuation of the surgical procedure.There was no harm or blood loss associated with the event.

• Brand Name: SARNS CENTRIFUGAL SYSTEM
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 9936238
• MDR Text Key: 195913966
• Report Number: 1828100-2020-00158
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K950739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 811474
• Device Catalogue Number: 811474
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1