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

Model Number 6379

Device Problems Improper Flow or Infusion (2954); Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As per field service representative (fsr), the perfusionist believes the vacuum was set up incorrectly.They corrected the vacuum line and proceeded to use the pump for the procedure.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, there was backflow visually noted when they started pumping.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.The field service representative (fsr) was unable to duplicate the reported complaint.The unit operated to the manufacturer's specifications.The surgical team believed the vacuum was set up incorrectly and once corrected there were no more reported issues.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: the perfusionist initiated bypass but was unable to come up to a good flow/revolutions per minute (rpm) ratio because she was getting poor return from her venous line.She informed the surgeon that she was receiving poor venous return and added vacuum suction to her venous reservoir.The suction was wall suction and was not regulated by a step down venous suction regulator.As she applied the -300/400 mmhg negative pressure to her venous reservoir, she pulled air into her circuit through the arterial line, back to the air bubble detector that was located just below her reservoir.Her circuit design does not have a retroguard valve.She clamped her arterial line and venous line to stop venous return from the patient.The surgeon and anesthesia staff had to stabilize the patient with volume and vasoconstrictors.Due to the user error, the surgeon opted not to use the heart lung machine (hlm) doing the procedure off-bypass.The field service representative (fsr) was asked to come check the system out and the system passed its specified tests.There was a change in the treatment of the patient, therefore a delay in the surgical procedure occurred.There was no harm or blood loss due to the use of the hlm.

• 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: 7300339
• MDR Text Key: 101251137
• Report Number: 1828100-2018-00099
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 03/12/2018; 04/16/2018
• Supplement Dates FDA Received: 04/06/2018; 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VACUUM; VENOUS RESERVOIR
• Patient Outcome(s): Required Intervention