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

Model Number 60-01-00

Device Problem Failure to Sense (1559)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) manufactures the sorin centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that the sorin centrifugal pump system with tubing clamp detected no flow during a procedure.There was no report of patient injury.A new flow probe was provided to the customer to resolve the reported issue.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the sorin centrifugal pump system with tubing clamp detected no flow 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).This medwatch report is being filed on behalf of livanova (b)(4) the livanova field service representative contacted the customer via phone.A new flow probe was provided to the customer to resolve the reported issue.No additional information received.If additional information is received it will be evaluated for reportability as required.A review of the dhr did not identify any manufacturing deviations or non-conformities relevant to the reported issue.The root cause was determined to be defective flow probe.Livanova has determined that a capa is not required, as there was no patient harm reported.Livanova will continue to monitor this issue for trends.

• Brand Name: SORIN 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: 6060542
• MDR Text Key: 58603129
• Report Number: 9611109-2016-00719
• 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: 01/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-01-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2009
• 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