MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-02-60

Device Problems Electrical /Electronic Property Problem (1198); Pumping Stopped (1503); Electro-Static Discharge (2149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).The device was sent to the (b)(4) service center for testing.The unit was tested over a one week period and the reported issue could not be reproduced.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

(b)(4) received a report that the centrifugal pump 5 (cp5) powered off during a procedure after receiving a small static shock when it was touched by the operator.The power switch of the device was immediately turned off and back on but unit did not restart.The operator tried again several seconds later and the device began working again.There was no report of patient impact.

Manufacturer Narrative

The device manufacturer date provided in the initial report was incorrect.The correct device manufacturer date is october 6, 2015.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The cp5 was returned to livanova (b)(4) for further investigation.During evaluation, the reported issue could not be reproduced.The device was functionally tested, tested in a climate chamber, and underwent "electric static discharge" testing.No deviations or abnormalities were identified.For safety reasons the cp5 is planned to be scrapped.As the issue could not be reproduced, a root cause was not determined.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6535764
• MDR Text Key: 74167682
• Report Number: 9611109-2017-00320
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: 010403381790100611151005
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2017

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: 60-02-60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2017
• Initial Date FDA Received: 05/01/2017
• Supplement Dates Manufacturer Received: 08/31/2017
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2015
• 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