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

Model Number 60-02-15

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided. 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). A livanova field service representative was dispatched to the facility to investigate. The service representative was unable to reproduce the reported fault. The drive unit of the centrifugal pump system was replaced as a precaution and subsequent functional testing was completed without issue. The unit was returned to service. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Evaluated on site by livanova technician.

Event Description

Livanova (b)(4) received a report that the flow of a centrifugal pump system with tubing clamp dropped unexpectedly during a procedure. The user determined that there was no obstruction in the line and increased the rpm to 2800 to increase flow to 3lpm. However, the customer reported that an rpm of 2800 should produce a higher flow than 3lpm. There was no report of patient injury.

• 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: 6974585
• MDR Text Key: 90853182
• Report Number: 9611109-2017-00857
• 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: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 60-02-15
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse