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

Model Number 10-80-00

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 03/29/2016

Event Type  Death  

Manufacturer Narrative

Device has not been returned to sorin group (b)(4).Sorin group (b)(4) manufactures the s5 roller pump.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 the s5 roller pump stopped without warning during procedure.A written system error appeared on the display module.The patient expired two days later, however the perfusionist has stated that the patient death is unrelated to the pump malfunction.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.Service investigates the device on site.

Event Description

Sorin group (b)(4) received a report that the s5 roller pump stopped without warning during procedure.A written system error appeared on the display module.The patient expired two days later, however the perfusionist has stated that the patient death is unrelated to the pump malfunction.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).A sorin group field service representative was dispatched to the facility to investigate the issue.Visual inspection and functional testing was unable to reproduce or confirm the described problem.The service representative tested the s5 level control sensor module together with the level sensor, but no errors or deviations were identified.The s5 roller pump was sent to sorin group (b)(4) for investigation.A 24 hour test run was performed and no errors or anomalies were identified.A serial readout was performed and sent to sorin group (b)(4) for analysis.Analysis of the readout did not identify any hardware or software errors on the date of the event.A technical safety inspection was successfully completed and the device was returned to the customer.Investigation of the involved device was unable to identify any issues related to the reported event.As the issue could not be reproduced, a root cause could not be determined and corrective actions were not identified.No further incidents have been reported by the facility regarding the sorin s5 system.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.Evaluated on site by sorin service rep.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5596156
• MDR Text Key: 43270326
• Report Number: 9611109-2016-00235
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2007
• 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
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Weight: 70