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

Model Number 6379

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 10/30/2014

Event Type  malfunction  

Event Description

It was reported that during the user of the device for a non-clinical activity, the delphin pumps used as backup for their system-1's were not holding a battery charge in the centrifugal system.There was no pt involvement.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.The perfusionist (ccp) was checking the unit when they found the issue.There was no pt involved.This unit is primarily used as back-up.The field service rep performed preventive maintenance (pm) inspection and confirmed the batteries were not holding a charge.He replaced the batteries and completed a release test.The unit operated to manufacturer specifications and was returned to clinical use.The suspect batteries were returned to the manufacturer for further evaluation.

• Brand Name: TERUMO CENTRIFUGAL SYSTEM
• Type of Device: SARNS CARDIOVASCULAR SYSTEM CORP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4293299
• MDR Text Key: 5054194
• Report Number: 1828100-2014-00991
• 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: 10/30/2014

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?: Yes
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2003
• 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