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

Model Number 60-02-60

Device Problems Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

The serial number has not been provided.This information will be provided in a follow-up report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a follow-up report if made available.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).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

Livanova (b)(4) received a report that the centrifugal pump 5 (cp5) displayed a "cp5 time out " message before the display of the control panel blacked out and rebooted by itself during priming.The device was used for the procedure and no further problems were noted.There was no patient involvement.

Manufacturer Narrative

The serial number was provided: (b)(4).Since the serial number was provided, the device manufacture date could be determined: 08.06.2015.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A review of he device read-out identified no software or hardware failure on the event date.The complete cp5 panel was asked back to livanova (b)(4) for further investigation.Upon device return, no damage was noticed on the external housing, on the internal cables or connectors, or on the pcbs during visual inspection the cp5 panel and the centrifugal pump were connected to the test bench, where they were tested at different speeds.No deviations occurred.The panel was then opened and a read out performed, no deviations were found.Further extensive test have been performed on the hkr board, including thermal preconditioning: no malfunction nor error messages were displayed.The power switch was replaced and a subsequent functional check was performed with no issue.The failure could not be reproduced during the investigation, therefore the root cause is unknown.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.

• 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: 6857002
• MDR Text Key: 85782143
• Report Number: 9611109-2017-00705
• Device Sequence Number: 1
• Product Code: DWA
• 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: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• 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