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

Model Number 10-80-00

Device Problems No Audible Alarm (1019); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2015

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.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 being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the s5 roller pump stopped without audible or visual alarm during procedure.There was no report of 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 roller pump stopped without audible or visual alarm during procedure.There was no report of patient injury.

Manufacturer Narrative

Sorin group (b)(6) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that the s5 roller pump stopped without audible or visual alarm during procedure.There was no report of patient injury.The complained unit was returned to sorin group (b)(4) for investigation.Evaluation of the returned s5 roller pump at sorin group could not reproduce or confirm the reported issue.Visual inspection of the returned device did not identify any anormalities or defects.The pump was functionally tested with slight and strong occlusion and no problems were found.An nvmem readout was performed, which did not identify any deviations.A hardware analysis was also unable to identify any issues.An endurance test of 2 weeks was performed using various speeds and configurations and no faults were detected during this time.The pcb motor control board was replaced as a precaution and the device was returned to the customer.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 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: 5231707
• MDR Text Key: 31641782
• Report Number: 9611109-2015-00562
• 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,Followup
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2007
• 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