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

Model Number 10-80-00

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 12/01/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that the s5 roller pump displayed an error message during a procedure.There was no patient injury.Follow-up communication with the biomedical engineer revealed that the issue was caused by the occlusion being set too high on the pump.The facility was able to resolve the issue on their own and the pump is back in service.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the s5 roller pump displayed an error message during a procedure.There was no patient injury.

Manufacturer Narrative

This is a follow up to the initial mdr submitted, stating an error message was displayed during a procedure which was later discovered by the customer to be due to the setting on the occlusion being set too high.There was no malfunction of the device, the device functioned as intended.The setting max load limit on the occlusion was met, which caused the error, and once the setting was adjusted the error was resolved.The investigation has been completed and it has been determined that the initial mdr was filed in error.There was no malfunction and the device functioned as intended.This is not reportable.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTCHSLAND; lindberghstr 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan caesar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5325332
• MDR Text Key: 34301943
• Report Number: 9611109-2015-00634
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/27/2017

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: 12/01/2015
• Supplement Dates FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2006
• 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