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 Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the ccp there was no backflow error or alarm observed.The field service representative (fsr) could not confirm the complaint.He performed all preventive maintenance (pm) and functional checks.No part will be returned.The unit operated to manufacturer specifications and was returned to clinical use.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a follow-up emdr will be filed accordingly.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the delphin drive unit's revolutions per minute (rpms) were way too high to generate flow.The device was not changed out, as the cannula was adjusted and flow returned to as expected.There was a delay in the surgical procedure of about one minute.The surgical procedure was completed successfully.There was no blood loss, nor adverse consequences to the patient.Per the clinical review on 04-apr-2016: the perfusionist (ccp) stated the patient was an average size adult patient and a 20 french aortic cannula was placed in the aorta and used for arterial blood return.There were no issues with flow generation during priming of the circuit and required pump speeds (rpms) were reasonable and at levels normally seen.The patient was cooled (during cpb) by drifiting with the resultant patient blood flow of about 3.5 liters per minute (l/min) at a pump speed of about 2600 rpms.During rewarming, after being on cpb for about one hour, the ccp observed a drop in measured blood flow to levels of about 1.5 - 1.7 l/min, even though the rpm was kept at about 2500 - 2600 rpms.According to the ccp, the arterial line circuit pressure did not increase.This lower than expected and desired flow rate remained for a few minutes and the ccp communicated to the cardiovascular (cv) surgeon that the flow had dropped.The cv surgeon inspected and manipulated the placement of the aortic cannula in attempt to isolate the cause for the drop in blood flow (a kink or placement issue would increase the resistance to blood flow).After manipulation of the cannula, the ccp stated the arterial blood flow rate returned to previous levels of 3.5 l/min at an rpm of about 2500.The ccp claims she saw no evidence of oxygenator obstruction, as there was no change in partial pressure of oxygen (po2) and/or partial pressure of carbon dioxide (pco2) levels and no clots / debris seen in the oxygenator when rinsed post case.The patient was weaned from cpb without issue and the case was completed successfully.There was no associated blood loss.There was a delay in the surgical procedure of about one minute, as the cv surgeon manipulated the aortic cannula.There was no harm observed.Though no malfunction of the hardware was confirmed during the procedure, the ccp would like the field service representative (fsr) to check out as a precaution.

• 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: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5604230
• MDR Text Key: 44191378
• Report Number: 1828100-2016-00279
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2012
• 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