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

Model Number 60-02-60

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2015

Event Type  malfunction  

Event Description

Sorin group received a report that the centrifugal pump momentarily turned off and then came back on during a procedure.There was no report of pt injury.

Manufacturer Narrative

Pt info was not provided.Sorin group (b)(4) manufactures the sorin centrifugal pump 5 (cp5).The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the centrifugal pump momentarily turned off and then came back on during a procedure.There was no report of pt injury.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.See scanned page.

Manufacturer Narrative

Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The event 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 checked the functionality of the unit and the cables and was unable to reproduce the reported issue.The software was updated to rev.210 and the unit was returned to service.As the issue was not reproduced, a root cause could not be determined.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Evaluated on-site by livanova technician.

• Brand Name: SORIN CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CARDIOPULMONARY BYPASS PUMP SPEED CONTROL
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; lindberghstr. 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: 4747723
• MDR Text Key: 5706478
• Report Number: 9611109-2015-00126
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2017

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: 60-02-60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2015
• Initial Date FDA Received: 04/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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