MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND GMBH S5 MAST ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE

Model Number 10-88-00

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2015

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned to sorin group (b)(4).Sorin group (b)(4) manufactures the s5 mast 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 mast roller pump displayed an error message during set-up.There was no patient involvement.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 mast roller pump displayed an error message during set-up.There was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the s5 mast roller pump displayed an error message during set-up.There was no patient involvement.A sorin group service representative was dispatched to the facility to investigate.The service representative evaluated the pump and confirmed the reported failure.The error code was displayed immediately upon turning the pump on.The service representative traced the error to the motor control board.The board was replaced and subsequent functional tests did not identify further issues.The pumpt was returend to service and the motor control board was returned to sorin group (b)(4) for investigation.Visual inspection of the returned device did not identify any abnormalities or defects.The board was connected to the s5 roller pump testbench, however the reported failure could not be reproduced.The supply voltages and pwm signals were tested and found to be within specification.The board was electrically and functionally tested without fault, and thermal testing in a climate chamber did not reproduce the reported issue.An endurance was also performed without fault.All tests performed were failure free.As the issue could not be reproduced, a root cause could not be determined and no corrective actions were 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 for trends related to this type of issue.

• Brand Name: S5 MAST ROLLER PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; 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: 5337393
• MDR Text Key: 34739085
• Report Number: 9611109-2015-00595
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K062396
• 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: Initial,Followup
• Report Date: 11/19/2015

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: 10-88-00
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2015
• 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