MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S3 CONSOLE FOR 3 PUMPS; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 43.30-00

Device Problems Device Inoperable (1663); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) manufactures the s3 console.The incident occurred in (b)(6).This medwatch report is filed on behalf of (b)(4).Sorin group received a report that the s3 wouldn't work during a procedure.There was no report of pt injury.The investigation is ongoing.A f/u report will be sent when the investigation is complete.

Event Description

Sorin group received a report that the s3 wouldn't work during a procedure.There was no report of pt injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the s3 console.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 device was tested but the reported failure could not be confirmed and the device worked according to specification.The service representative replaced the batteries due to age and placed the unit back into service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Livanova deutschland will continue to monitor for trends related to this type of issue.Evaluated on site by livanova technician.

• Brand Name: S3 CONSOLE FOR 3 PUMPS
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; lindberghstr. 25; munchen ; GM
• 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: 5048898
• MDR Text Key: 25220844
• Report Number: 9611109-2015-00314
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 02/22/2017

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: 43.30-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2002
• 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