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

Model Number 6382

Device Problem False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the flow sensor had a back flow alarm that kept alarming but there were no back flows.The customer continued to use the device.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.As per clinical review: a sarns centrifugal system was being used and was mounted on the sarns 8000 heart lung machine (hlm) base.Periodically during this procedure, backflow alarms occurred even though no backflow conditions were observed.Backflow can be observed by rising of blood levels in the venous reservoir and an associated drop in patient blood pressure and arterial line pressure (cpb circuit).These other indicators of backflow did not exist and thus the backflow alarms were considered false triggers.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

The field service representative (fsr) was unable to duplicate the problem.The fsr replaced the flow sensor.The unit operated to manufacturer's specification.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) could not to reproduce the reported issue.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: 6325286
• MDR Text Key: 67535987
• Report Number: 1828100-2017-00064
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2010
• 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