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

Model Number 10-80-00

Device Problems Blank screen (1063); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2015

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 received a report that the roller pump touch screen was unresponsive during set up.There was no pt involvement.The investigation is ongoing.A f/u report will be sent when the investigation is complete.

Event Description

Sorin group received a report that the roller pump touch screen was unresponsive during set up.There was no pt involvement.

Manufacturer Narrative

(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 touch screen and accessories were replaced and the nvmem was cleared.Subsequent functional testing found no further issues and the unit was returned to service.No further occurrences have been reported for this unit.Photos of the kapton-tail connection of the touch screen were provided to livanova (b)(4) for evaluation.The photos showed signs of fluid ingress into the touch screen, which led to oxidation of contacts and electrical failure.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 ; lindberghstr. 25; munich D 809 39; GM D 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: 5060686
• MDR Text Key: 25224998
• Report Number: 9611109-2015-00323
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• 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