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

Model Number 60-01-00

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

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).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that the bio head of the centrifugal pump system with tubing clamp was stuck in its place during a procedure.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.He could confirm the reported issue and could fix it by cleaning the locking pin.After that cleaning action the locking pin was free and locked the revolution head properly.As root cause inadequate cleaning by the customer was determined.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.

• Brand Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Type of Device: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• 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: 6814248
• MDR Text Key: 83749623
• Report Number: 9611109-2017-00657
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

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: 60-01-00
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 01/15/2018
• Supplement Dates FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2011
• 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