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

Model Number 6379

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As per manufacturing engineering center, this issue could not be duplicated, but they confirmed a dot failure on part of the display.

Event Description

The user reported that during weaning from cardiopulmonary bypass, the centrifugal pump stopped suddenly when it was running at about 1300 revolution per minute (rpm).As a result, an alternate device was employed.There were no reported adverse consequences to the patient.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Event Description

Received additional information that the device was not changed out and that the surgical procedure was completed successfully.Per clinical review on jan 9, 2017.During the last few minutes of cardiopulmonary bypass (cpb), weaning from cpb had started.Weaning is the process of gradually filling of the patient's heart and simultaneously reducing blood flow from the cpb circuit.In this case, weaning had begun and in fact the rpm was at 1300 rpm and the user observed no blood flow.According to the manufacturer's subsidiary, the user is under the impression the motor stopped, but at a speed of 1300 rpm low flow or no flow would be expected.The patient was weaned from cpb successfully without need for handcranking or change out.After cpb was completed, the centrifugal system was removed from service.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst), connected the centrifugal motor and flow sensor centrifugal controller.The flow sensor was attached to a water loop that was driven by the motor.The controller was operated for 72 hours with no stoppage occurring.The controller, motor and flow sensor was placed into cold soak at 10 degree celsius for three hours and when removed from cold soak, the controller operated for 24 hours with no stoppage occurring.The controller was opened and checked for loose connections with none found that would cause failure.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 CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6191646
• MDR Text Key: 63191549
• Report Number: 1828100-2016-00802
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K950739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2008
• 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