MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 CONSOLE FOR 4 PUMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 48-40-00

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin centrifugal pump 5 (cp5).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 customer was originally having problems when trying to access the service menu.The service representative evaluated the device and was unable to activate or deactivate any of the icons on the display; the touchscreen was completely unresponsive.The touchscreen was replaced to resolve the issue.A review of the dhr could not identify any deviations or non-conformities relevant to the reported issue.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 touch screen of the sorin centrifugal pump 5 (cp5) did not work post procedurally.There was no report of patient injury.

Manufacturer Narrative

Livanova(b)(4) performed a visual inspection in house on the returned part and could confirm the failure.Fluid had penetrated into the capton tail, which could have caused oxidation.Root cause fluid/moisture ingress was determined.

Event Description

Cp5 touchscreen not working.Customer complain that they are unable to go into the service menu.97-103-617 led display w.Touchscreen s5.96-231-043 ribbon cable 33-l.X tft-displ.96-231-045 flat ribbon cable p06.Service confirmation: 9000021380, frozen cp5 touchscreen.Srd s5 console for 4 pump 48e03146.Cp5 touchscreen not working.Cp5 touchscreen not working.

• Brand Name: S5 CONSOLE FOR 4 PUMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6183262
• MDR Text Key: 62715556
• Report Number: 9611109-2016-00955
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112225
• 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: 11/18/2016

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: 48-40-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: 01/25/2017
• Supplement Dates FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• 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