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

Model Number 6379

Device Problem Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the field service representative (fsr) there was a flowrate displayed when there was no flow.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, erratic flows were displayed.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Manufacturer Narrative

The field service representative (fsr) verified the erratic flow.The fsr replaced the defective flow board.The unit operated to the manufacturer's specifications.During laboratory analysis, the product surveillance technician (pst) observed no inconsistencies in flow reporting throughout testing.The device under test (dut) readout remained within specification for all readings.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

The reported complaint was confirmed.Although there were no erratic readings observed during evaluation, residue contamination of the flow sensor connector can sometimes produce intermittent connection which may cause this effect and be a contributing factor to 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 CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 7196228
• MDR Text Key: 97792736
• Report Number: 1828100-2018-00023
• 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,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/18/2018
• Initial Date Manufacturer Received: 12/26/2017
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 01/18/2018; 03/27/2018; 04/06/2018
• Supplement Dates FDA Received: 02/12/2018; 04/05/2018; 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1