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

Model Number 60-02-60

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was not able to confirm the reported issue.Subsequent functional verification testing was completed without issues and the unit was returned to service.Further investigation revealed that the reported issue is not a malfunction.The device worked as intended.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Device not returned.

Event Description

Livanova (b)(4) received a report that centrifugal pump5 (cp5) did not ramp up after an alarm was cleared during procedure.There was no report of patient injury.

• 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 ; 1401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 7364815
• MDR Text Key: 103674193
• Report Number: 9611109-2018-00254
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: 010403381790100611170719
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-60
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2017
• 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