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

Model Number 6382

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2019

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the flow sensor was not reading.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the team had an issue with the stand alone centrifugal pump during a cpb procedure on (b)(6) 2019.The stand-alone centrifugal pump was primed without issue.About half way through the procedure, the light emitting diode (led) on the display of the pump flow were displaying.035 liters per minute (l/min).The perfusionist changed his flow probe and it was still displaying a.035 number.The end user decided to proceed without exchanging the flow probe, for he was able to see that his revolutions per minute (rpm) were what he expected them to be, and his patients pressures along with venous saturation levels were as expected.He deduced that the display was the concern not the actual flow probe or centrifugal pump, therefore he felt comfortable without exchanging the entire module.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss due to the event.

Manufacturer Narrative

The reported complaint was not verifiable.Multiple diligence attempts for part return were unsuccessful so no evaluation could be performed.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: 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: 8969792
• MDR Text Key: 159611112
• Report Number: 1828100-2019-00472
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6382
• Device Catalogue Number: 6382
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1