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

Model Number 10-80-00

Device Problems Device Inoperable (1663); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2015

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 roller 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 pump touchscreen was unresponsive after the procedure was complete.There was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(6) received a report that the pump touch screen was unresponsive after the procedure was complete.There was no patient involvement.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 roller pump.The event occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to reproduce the reported issue.The service representative did not identify any signs of liquid ingress into the pump panel or the touch screen and the surface of the touch screen was not externally damaged.The display, pcb hkr0325, ribbon cable 6 pole, speaker cable, ribbon cable 33 pole, and the pump joint parts were replaced.Subsequent functional verification did not identify further issues.A photograph of the replaced touch screen was sent to livanova (b)(4) for evaluation and it was determined that there in fact were signs of fluid ingress.This is a known issue for which a capa (b)(4) has already been implemented.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; lindbergh strasse 25; munich ; GM
• 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: 5001255
• MDR Text Key: 24433946
• Report Number: 9611109-2015-00284
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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