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

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2016

Event Type  No Answer Provided  

Manufacturer Narrative

This event involved an s5 double head pump (model number 10-85-00, serial number (b)(4)) and an s5 single roller pump (model number 10-80-00, serial number (b)(4)).It is not known which pump experienced the failure.Device manufacture date (mm/dd/yyyy): 10-85-00 / (b)(4) - 07/09/2014; 10-80-00 / (b)(4) - 07/07/2014.Sorin group (b)(4) manufactures the s5 double head pump and the s5 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).The s5 double head pump (10-85-00) being used for cardioplegia delivery was stop linked to the arterial s5 roller pump (10-80-00).The cardioplegia pump should have stopped when the arterial pump stopped.A serial readout was performed on both pumps and was sent to sorin group (b)(4) for further investigation.Analysis of the serial readout did not identify any hardware or software failures stored in the processor on the event date.Further analysis is not possible, as both pumps have been used since the incident and the data has been overwritten.A sorin group field service representative was dispatched to the facility to investigate.The service representative evaluated the unit and was unable to identify any issues.The entire s5 system was serviced according to the preventative maintenance guidelines and full functional and electrical safety tests were performed without issue.The units were returned to service.As the issue could not be reproduced, 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.Sorin group (b)(4) will continue to monitor the market for trends related to this type of issue.Evaluated on site by sorin service rep.

Event Description

Sorin group (b)(4) received a report that the cardioplegia delivery s5 double head pump lost the stop link to the arterial s5 roller pump.The display showed the stop link still active, but the cardioplegia delivery double pump continued to run when the arterial pump stopped.There was no report of patient injury.

• 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: 6108193
• MDR Text Key: 60091841
• Report Number: 9611109-2016-00752
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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