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

Model Number 10-60-00

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Patient information was not provided.The model and serial number of the pump were not provided, and the unique identifier (udi) number could not be determined.This information will be provided in a supplemental report of and when made available.As the serial number was not provided, the date of manufacture could not be determined.This information will be provided in a supplemental report of and when made available.Sorin group (b)(4) manufactures the 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 worked with the customer and provided instruction for how to remove and clean the roller.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 one of the roller wheels of the s3 roller pump became stuck during a procedure.There was no report of patient injury.

Manufacturer Narrative

Additional device information: model number: 10-60-00, serial number: (b)(4).Device manufacture date: 11/15/2005.Sorin group (b)(4) manufactures the s3 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Through follow-up communication with the customer on november 17, 2016, sorin group deutschland learned the model and serial number of the involved pump (model 10-60-00 serial number (b)(4)).Communication with the sorin group field service representative on november 22, 2015 revealed that the issue was related to the white tubing guide rollers.

• 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: 6073026
• MDR Text Key: 59065644
• Report Number: 9611109-2016-00740
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/14/2016

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2005
• 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