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

Model Number 60-02-15

Device Problems Device Operational Issue (2914); Physical Property Issue (3008)

Patient Problem No Patient Involvement (2645)

Event Date 02/08/2017

Event Type  malfunction  

Manufacturer Narrative

(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 (b)(4).A (b)(4) field service representative was dispatched to the facility to investigate.The service representative tightened the guide sleeve (60-02-02) of the encoder to resolve the reported issue.Subsequent testing found no further issues and the unit was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Evaluated on site by (b)(4) technician.

Event Description

(b)(4) received a report that the encoder of the centrifugal pump system with tubing clamp would not control the flow speed during priming.The user stated that the knob was found to be loose.There was no patient involvement.

• 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; lindberghstrasse 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6404820
• MDR Text Key: 69951929
• Report Number: 9611109-2017-00175
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817900986
• UDI-Public: 010403381790098611150907
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K032213
• 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: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2016
• 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