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

Model Number 6379

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) replaced the flow printer circuit board (pcb).The unit operated to the manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the unit was not reading any flows.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

Updated event problem and evaluation codes.The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the module displayed flow and signal strength of over 100% with the flow printed circuit (pc) board installed in a lab-use centrifugal control module.No loss of flow display occurred during the two days of testing.The unit operated to the manufacturer's specifications.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: 8448982
• MDR Text Key: 139738511
• Report Number: 1828100-2019-00151
• 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
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• 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: 03/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1