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

Model Number 6382

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) verified the flow sensor would not display readings and the signal strength was 0%.The fsr removed the suspect flow sensor, installed new flow sensor and performed a release test.The unit operated to manufacturer specifications and was returned to clinical use.The suspect part was returned to the manufacturer for further evaluation.The reported complaint was confirmed during laboratory evaluation.The product surveillance technician (pst) observed no flow readings from the returned flow sensor.The pst connected the flow sensor to a flowmeter module which was connected to a system 1 simulator.He attached the sensor¿s head to a water loop driven by a centrifugal motor and controller.The pst started flow through the water loop and no flow reading was received from the flow sensor.He agitated the flow sensor¿s cable, connector and head but there was still no flow reading from the flow sensor.During visual inspection nothing observed that would cause failure.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 priming of the device for a cardiopulmonary bypass procedure, the flow sensor was not showing flow reading (showing zero).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.

• 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: 5630831
• MDR Text Key: 44892540
• Report Number: 1828100-2016-00306
• 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: 05/04/2016

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: 6382
• Device Catalogue Number: 6382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2016
• Initial Date FDA Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2015
• 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