MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND CENTRIFUGAL PUMP CONSOLE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 60-03-75

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

Patient Problem No Patient involvement (2648)

Event Date 07/06/2015

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the centrifugal pump console.The incident occured 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.

Event Description

Sorin group (b)(4) received a report the centrifugal pump touch screen was unresponsive during set up.There was no patient involvement.

Manufacturer Narrative

Livanova (b)(4) manufactures the centrifugal pump console.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 was able to reproduce the reported issue.The touch screen was replaced to resolve the issue and a recalibration was performed.The unit was functionally tested and returned to service.No further issues have been reported for this unit.Further investigation could not be performed, as the customer scrapped the defective touch screen.Considering the manufacturing date of the pump, it is likely that the touch screen falls under rci (b)(4).However, an exact root cause could not be determined.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Scrapped by customer.

• Brand Name: CENTRIFUGAL PUMP CONSOLE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: 4963823
• MDR Text Key: 22388830
• Report Number: 9611109-2015-00268
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K020571
• 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: 03/20/2017

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: 60-03-75
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/07/2015
• Initial Date FDA Received: 07/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2006
• 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