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

Model Number 10-80-00

Device Problem Failure to Conduct (1114)

Patient Problem No Patient Involvement (2645)

Event Date 02/27/2019

Event Type  Death  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(6).Through follow-up communication with the customer, livanova deutschland learned that the biomed replaced a processor board to fix the issue.The affected part was requested for return to be investigated at livanova deutschland.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Investigation not begun.

Event Description

Livanova deutschland received a report that on a s5 roller pump the speed knob didn't work when it was rotated.There was no patient involvement.

Manufacturer Narrative

During the visual inspection, several non-conforming soldering joints have been detected on the processor board.The non-conforming soldering joints have been identified as the root cause of the reported issue.Corrective actions are in progress for this issue.

Event Description

See initial.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 89309 ; GM 89309
• Manufacturer Contact: njemile crawley ; 14401 w. 65th way; arvada, CO 80004 ; 2812287575
• MDR Report Key: 8460210
• MDR Text Key: 140314528
• Report Number: 9611109-2019-00193
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)180409
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2018
• 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