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

Model Number 6379

Device Problem Failure to Sense (1559)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the delphin centrifugal controller module did not work.As a result, the user facility tried using the ultrasonic sensor on another unit and it worked.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The field service representative (fsr) verified the control module was not reading flow.Troubleshooting found that the control module printed circuit board assembly (pcba) was the source of the problem.The fsr replaced the control module flow pcba.The unit operated to the manufacturer's specifications.The defective part was returned to the manufacturer for further evaluation.

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) swapped the device under test (dut) flow board assembly into a lab use only delphin controller.The flow readout remained 0.00 throughout the full speed range of the delphin, which duplicated the reported complaint.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: 6267499
• MDR Text Key: 65692136
• Report Number: 1828100-2017-00029
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• 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: 11/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/1995
• 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