MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-02-15

Device Problem Physical Property Issue (3008)

Patient Problem No Patient Involvement (2645)

Event Date 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The livanova field service representative on site to perform routine maintenance tightened the loose control knob and returned the device to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Livanova (b)(4) will continue to monitor for trends related to this type of issue.Evaluated on site by livanova technician.

Event Description

Livanova (b)(4) received a report that the encoder of the centrifugal pump system with tubing clamp was found to be loose during maintenance.This issue was identified by a livanova field service representative while on site performing routine service.There was no patient involvement.

Manufacturer Narrative

(b)(4).The udi number provided in the initial report, submitted march 6, 2017, was for the wrong serial number.The correct serial number ((b)(4)) does not have a udi number, as it was manufactured in 2014.Device manufacture date (mm/dd/yyyy): 09/29/2014.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• 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: 6380616
• MDR Text Key: 69213219
• Report Number: 9611109-2017-00172
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2017

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: Other
• Device Model Number: 60-02-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 03/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2014
• 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