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

Model Number 10-80-00

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

Patient Problem No Patient involvement (2648)

Event Date 12/05/2014

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report that the touch screen of the s5 roller pump was unresponsive during set up.There was no patient involvement.

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).The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

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 confirmed the reported unresponsive touch screen.The device was returned to livanova (b)(4) and the faulty touch screen and the processor board were both replaced and subsequent testing did not identify further issues.The unit was returned to the customer.A photograph of the kapton-tail date-code of the faulty touch screen was provided to livanova (b)(4) for further investigation.Analysis of the photograph confirmed that the ageing and wear has caused this malfunction, a review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.A root cause investigation ((b)(4)) was initiated for this type of issue.Evaluated on site by livanova technician.

• Brand Name: S5 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): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 4387933
• MDR Text Key: 5304780
• Report Number: 1718850-2014-00491
• 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
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• 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: 02/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2007
• 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