MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 DOUBLE HEAD PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-85-00

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2014

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report that the touch screen of the s5 double head pump was unresponsive during a procedure.There was no report of patient injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

Report number: the report number in the previous supplemental report filed for this complaint was incorrect.Follow-up # 1 for this complaint was filed under medwatch report number 9611109-2015-00494, but the correct medwatch report number is 1718850-2014-00494 (as seen on this report).

Manufacturer Narrative

This report was initially submitted on december 16, 2015.However, the report was accidentally submitted as 9611109-2015-00494 instead of 1718850-2014-00494.A second follow-up was filed on january 15, 2016 in order to identify this error.However, we are now receiving a duplicate report error for the actual 9611109-2015-00494 report.This report is being re-filed with the accurate report number to correct the error, and the erroneous report will be voided in the fda system.Sorin group (b)(4) manufactures the s5 double head 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 touch screen of the s5 double head pump was unresponsive during a procedure.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate.While at the facility, the service representative replaced the complained touch screen with a new touch screen and cleared the nvmem according to the s5/c5 touchscreen replacement field engineering note.The console revision was updated and functional check performed.No further issues were discovered.Photographs of the replaced touch screen were sent to sorin group (b)(4) for evaluation.After reviewing the photos, it was determined that liquid had penetrated into the touch screen, causing the reported issue.This is a known issue and capa (b)(4) has already been opened to address this issue.Change order (b)(4) has already been implemented as a correction.

• Brand Name: S5 DOUBLE HEAD PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich ; GM
• 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: 4379355
• MDR Text Key: 5115976
• Report Number: 1718850-2014-00494
• Device Sequence Number: 1
• Product Code: DTQ
• 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,health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-85-00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• 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