MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND GMBH 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 Patient involvement (2648)

Event Date 06/24/2015

Event Type  Other  

Event Description

Sorin group received a report that the centrifugal pump control panel shut off and turned black.Another console was used.As this occurred during set up, there was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin centrifugal pump 5.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

Livanova (b)(4) manufactures the centrifugal pump 5.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The reporting customer is trained on the repair of this device and did not wish to return the device for investigation.Additionally, no service was requested.Livnova (b)(4) has not been made aware of any additional issue with the reported unit.As an investigation on the involved device could not be performed, a root cause could not be determined and corrective actions were not identified.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Livanova (b)(4) will continue to monitor for trends related to this type of issue.

• Brand Name: SORIN CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CARDIOPULMONARY BYPASS PUMP SPEED CONTROL
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; lindbergh strasse 25; munchen 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: 4950537
• MDR Text Key: 19497267
• Report Number: 9611109-2015-00253
• 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: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• 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
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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