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

Model Number 50-80-00

Device Problems No Display/Image (1183); Failure to Pump (1502)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Patient information was not provided.Device has not been returned to sorin group (b)(4).Sorin group (b)(4) manufactures the s5 mast roller pump.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 display of the s5 mast roller pump control panel was black and the pump could not be during the procedure.The pump was restarted multiple times and the perfusionist was able to use the pump for the procedure.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate.A serial readout was performed and the date was sent to sorin group deutschland for investigation.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.Serial readout performed, sent to sorin.

Event Description

Sorin group (b)(4) received a report that the display of the s5 mast roller pump control panel was black and the pump could not be during the procedure.The pump was restarted multiple times and the perfusionist was able to use the pump for the procedure.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).This medwatch report is filed on behalf of livanova (b)(4).A serial readout was performed and the data was sent to livanova (b)(4) for investigation.There were no hard or software faults filed in the serial readout reviewed of the pump data.The pump was found to be incorrectly connected.The pump position was switched and used as a sucking pump; no further problems were reported.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The root cause of the reported issue was found to be related to a incorrectly connected pump.Livanova has determined that a capa is not required, as there was no patient harm reported.Livanova will continue to monitor this issue for trends.

• Brand Name: S5 MAST 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: 5699480
• MDR Text Key: 46567146
• Report Number: 9611109-2016-00321
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/08/2018

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: 50-80-00
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2016
• Initial Date FDA Received: 06/03/2016
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2012
• 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