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 Loss of consciousness (2418)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

Patient identifier, age and weight were not provided.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 noise was noted coming from inside the s5 roller pump for 15-20 seconds prior to the pump stopping during a procedure.The unit alarmed and displayed an error message.The pump was hand cranked for three and a half minutes until the pump could be swapped out.The change out took a total of 5 minutes.The patient is still in the intensive care unit and has not yet woken up.The patient status cannot be fully assessed until the patient wakes up.A sorin group field service representative was dispatched to the facility to investigate.The unit was inspected and tested and no signs of damage or fluid ingress were noted.The service representative was unable to reproduce the noise or vibration.A serial readout was performed and the results along with the unit were returned to sorin group deutschland for further investigation.Visual inspection of the returned s5 roller pump did not identify any deviations or abnormalities.Functional testing and hardware analysis also did not identify any deviations.The pump was tested with varying occlusion levels and no issues were observed.All connections were checked and found to be okay.The pump was tested in a climate chamber at 10°c and 50°c, which revealed no electrical or mechanical problems.An endurance test of 36 hours at different speeds and different configurations did not reproduce the issue.Analysis of the serial readout confirmed that the pump stopped and displayed an error message on the reported date.The failure identified in the serial readout can occur if the tubing is kinked and/or the occlusion is too strong.A technical safety inspection performed on the unit found no other issues.The unit was returned to the customer.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.

Event Description

Sorin group (b)(4) received a report that noise was noted coming from inside the s5 roller pump for 15-20 seconds prior to the pump stopping during a procedure.The unit alarmed and displayed an error message.The pump was hand cranked for three and a half minutes until the pump could be swapped out.The change out took a total of 5 minutes.The patient is still in the intensive care unit and has not yet woken up.The patient status cannot be fully assessed until the patient wakes up.

• 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: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5814399
• MDR Text Key: 50175554
• Report Number: 9611109-2016-00434
• 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: 06/22/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2015
• 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): Other