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

Model Number 10-80-00

Device Problems Failure to Pump (1502); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Sorin group (b)(6) manufactures the s5 roller pump.The incident occurred in.(b)(6) this medwatch report is filed on behalf of sorin group (b)(6).Sorin group (b)(6) received a report that the s5 roller pump displayed an error message during priming.There was no patient involvement.A sorin group field service representative was dispatched to the facility to investigate.A data acquisition was performed and the error was confirmed.The hkr processor board was replaced and returned to sorin group (b)(6) for evaluation, which is in progress.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 s5 roller pump displayed an error message during priming.There was no patient involvement.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is filed on behalf of livanova (b)(4).Livanova (b)(4) requested that the hkr 0325 be returned for further investigation.The unit was received for inspection and analysis; according to inspector the reported issue could be reproduced at low temperatures.After re-soldering of the ic1 processor was re-soldered and the subassembly worked faultless at all temperatures.A review of the dhr did not identify any deviations or nonconformities relevant to the issue.A root cause investigation (rci 2016-02) has been opened to investigate this type of issue and determine if further corrective actions are necessary.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA 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: 5696504
• MDR Text Key: 46465969
• Report Number: 9611109-2016-00312
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K071318
• 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: 11/06/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 06/02/2016
• Supplement Dates Manufacturer Received: 10/18/2017
• Supplement Dates FDA Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2009
• 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