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

Model Number 60-01-04

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The event occurred in (b)(6).A livanova service representative was dispatched to the facility to investigate.The service representative was able to reproduce the reported error.The drive unit was removed and sent back to livanova (b)(4) for investigation.During evaluation at livanova (b)(4), the failure was confirmed and visual inspection identified an issue with the motor.When disassembled, the crimp contacts of the hall sensor board were found to be detached, and one hall sensor component was damaged.After replacement of the centrifuge motor and a complete functional check, the device was found to be working according to expectation and was returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The cause of the faulty motor could not be identified, however fluid ingress is suspected.

Event Description

Livanova (b)(4) received a report that a centrifugal pump 5 (cp5) displayed an error during a procedure.The console was replaced to continue the surgery.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 ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 7463140
• MDR Text Key: 106596814
• Report Number: 9611109-2018-00933
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817900948
• UDI-Public: 010403381790094811171218
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/25/2018

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: 60-01-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2018
• 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