MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP 5 (CP5) ; CARDIOPULMONARY BYPASS PUMP SPEED CONTROL

Model Number 60-00-60

Device Problems Loose or Intermittent Connection (1371); Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2015

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report the centrifugal pump stopped during a procedure.Dashes were shown on the display.There was no report of patient injury.Intermittent failure.

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin centrifugal pump 5 (cp5).The incident occured in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the centrifugal pump stopped during a procedure.Dashes were shown on the display.There was no report of patient injury.The investigation is ongoing.A follow-up will be sent when the investigation is complete.

Manufacturer Narrative

Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).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 cp5 was removed from service and returned to livanova (b)(4) for further investigation.Visual inspection of the device at livanova (b)(4) did not identify any abnormalities or defects.Functional testing was able to reproduce the reported issue.The flow board was identified as faulty and was replaced to resolve the issue.The device was tested for 24 hours without further failures.The device was returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• Brand Name: SORIN CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CARDIOPULMONARY BYPASS PUMP SPEED CONTROL
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; lindbergh strasse 25; munich D 809 39; GM D 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: 4960905
• MDR Text Key: 6252532
• Report Number: 9611109-2015-00266
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2017

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: Health Professional
• Device Model Number: 60-00-60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2015
• Initial Date FDA Received: 07/29/2015
• Supplement Dates Manufacturer Received: 02/19/2016
• Supplement Dates FDA Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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