MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND GMBH S5 SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 48-30-00

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 system.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that during the s5 system lost power nd turned off during a procedure, after approximately 30 seconds of hand-cranking.Power cycling the system resolved the problem and the procedure was completed w/out further issues.It was also reported that the system was checked by an engineer at the facility and the issue could not be reproduced.There was no patient injury.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 that the s5 system lost power and turned off during a procedure, after approximately 30 seconds of hand-cranking.Power cycling the system resolved the problem and the procedure was completed w/out further issues.It was also reported that the system was checked by an engineer at the facility and the issue could not be reproduced.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).This medwatch report is filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative tested the device extensively but was unable to confirm or reproduce the reported malfunction.A preventive maintenance was performed without issue and the device was returned to service.A serial read out was performed and sent to livanova (b)(4) for further evaluation.Analysis of the read out did not identify any failures.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: S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; 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: 5038567
• MDR Text Key: 24686181
• Report Number: 9611109-2015-00306
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Unknown
• 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

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48-30-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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