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 Consequences Or Impact To Patient (2199)

Event Date 05/03/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) manufactures the s5-roller pump 150.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 s5 roller pump displayed an error message and stopped during a procedure.The the pump was restarted after a few seconds and the case continued without further issue.There was no report of patient injury.A sorin group field service representative was dipatched to the facility to investigate and was unable to reproduce the reported issue.The perfusionist did not note the specific error code that appeared but noticed a wrench symbol.A serial readout was performed and the data was sent to sorin group (b)(4) for analysis, where it was confirmed that an error related to the speed control encoder had occurred.The speed encoder was replaced and a full functional check was carried out without issue.The unit was released to the customer.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.Repaired on site by sorin service rep.

Event Description

Sorin group (b)(4) received a report that the s5 roller pump displayed an error message and stopped during a procedure.The the pump was restarted after a few seconds and the case continued without further issue.There was no report of patient injury.

Manufacturer Narrative

(b)(4) manufactures the s5-roller pump 150.The incident occurred in (b)(6).This medwatch report is filed on behalf of (b)(4).(b)(4) requested that the shaft encoder be returned for further investigation.The unit was received for inspection and analysis; according to the inspector no problem could be found with the encoder.All performed tests were without any faults.For safety reasons the shaft angle encoder was scrapped.The root cause was unable to be determined.A problem with the encoder was filed in the pump memory, but the further investigation of the encoder could not confirm the reported issue.A review of the dhr did not identify any deviations or nonconformities relevant to the issue.As there is no trend for this kind of issue no corrective action is necessary; (b)(4) will continue to monitor the market for trends related to this type of issue.

• 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: 5693559
• MDR Text Key: 46361658
• Report Number: 9611109-2016-00306
• Device Sequence Number: 1
• Product Code: DWB
• 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
• 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: 05/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: 10/18/2017
• Supplement Dates FDA Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2013
• 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