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

Model Number 10-80-00

Device Problem Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).The serial read out of the pump has been analyzed.The pump stop could be caused by the level alarm which occurred 2 minutes before the hand-cranking started or by the several cover stop alarms which occurred between the level stop and the hand cranking.Based on these results, it is reasonable to assume that the device was working according to specifications.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that a s5 roller pump stopped during procedure.The user hand-cranked the pump and then used another pump to complete the case.The user did not notice any error or alarm when the pump stop.There was no report of patient injury.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 9486280
• MDR Text Key: 196572291
• Report Number: 9611109-2019-00971
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K071318
• 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
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• 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: 11/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2006
• 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