MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CENTRIFUGAL SYSTEM; SARNS CENTRIFUGAL SYSTEM

Model Number 6382

Device Problems Erratic or Intermittent Display (1182); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the flow on the flow sensor was erratic during morning set-up.As a result, an alternate device was employed.All cases cancelled the day of event for unknown reasons.Not related to equipment issues.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The field service representative (fsr) performed preventative maintenance the day before.The fsr investigated reported issue and could duplicate the issue.The delphin would display "back flow" error message with static water in tubing.The issue would go away when the cable to the flow sensor at the connector to the delphin was manipulated.The fsr replaced the flow sensor and completed preventative maintenance (pm).The unit operated to manufacturer specifications and was returned to clinical use.The suspect device was returned to the manufacturer for further evaluation.

• Brand Name: TERUMO CENTRIFUGAL SYSTEM
• Type of Device: SARNS CENTRIFUGAL SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3805340
• MDR Text Key: 21878394
• Report Number: 1828100-2014-00132
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• 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?: Yes
• Date Returned to Manufacturer: 02/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2004
• 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