MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S3 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-60-00

Device Problems Failure to Pump (1502); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Patient information was not provided.(b)(4) manufactures the sorin s3 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).A sorin group field service representative was dispatched to the facility to investigate.The service representative learned that the pump was used in a case two hours earlier without incident.Before the error occurred, the customer reported to have left the pump on at 0 rpms before attempting to start.Inspection of the device found that the front panel was damaged and the speed adjustment knob was rattling.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 when the user attempted to start the s3 roller pump, it did not start and an error message was displayed.The pump was restarted and the issue was resolved.The surgery was performed without further incident.However, the pump was removed from service following the completion of the case.There was no report of patient injury.

Manufacturer Narrative

Through follow-up communication with the service representative, sorin group (b)(4) learned that the front panel was replaced and the pump was returned to service.

• Brand Name: S3 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: 6282986
• MDR Text Key: 65961431
• Report Number: 9611109-2017-00002
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

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: 10-60-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/29/2016
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2006
• 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