MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND MAST ROLLER PUMP 150; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-88-00

Device Problems Pumping Stopped (1503); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).A sorin group field service representative was dispatched to the facility to investigate.The service representative learned that an error was not displayed during the event and the user was able to resolve the issue by restarting the pump.The case was continued without further issue.The service representative replaced the mast mounted roller pump and control panel.Subsequent functional testing did not identify further issues and the unit was returned to 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 mast roller pump stopped flowing and the speed control knob became unresponsive during a procedure.There was no report of patient injury.

Manufacturer Narrative

Livanova usa performed an in house investigation on the returned parts with the following results.S5 variolock tubing clamp and s5 mast roller pump were installed on the s5 test bed and tested for 3 hours at various speeds with no issues encountered with pump operation.The lower corners of the touch screen were not always responsive likely due to the spills shown in the visual inspection.Other than touch screen response, the devices operated as intended.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.

Event Description

The arterial pump head stopped flowing during cpb and the controller rpm knob was unresponsive.The pump stopped, but no error was displayed.The operator was able to power down/up and continue case without further incident.

• Brand Name: MAST ROLLER PUMP 150
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP 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: 6307425
• MDR Text Key: 66771317
• Report Number: 9611109-2017-00026
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-88-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2007
• 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