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

Model Number 10-88-00

Device Problems Failure to Pump (1502); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 01/04/2017

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Sorin group (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).(b)(4).A sorin group field service representative was dispatched to the facility to investigate.The service representative was able to reproduce the issue and noticed the cover open alarm on the mast pump was constantly active, indicating an open cover and preventing the pump from rotating.Inspection found that the magnet was missing from underneath the pump cover, thus triggering the alarm even with the lid closed.The service representative replaced to resolve the issue.A subsequent functional verification test was successfully completed and no other issues were identified.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.A capa ((b)(4)) has been opened to perform a design change to address this type of issue.Change order (b)(4) has already been implemented as a correction.Evaluated on site by sorin service rep.

Event Description

Sorin group (b)(4) received a report that the perfusionist noticed that the mast roller pump would not rotate or respond to knob control during priming.The operator did not notice that the pump cover indicator was red and activated.The roller pump was exchanged for the procedure.There was no patient involvement.

• Brand Name: S5 MAST ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6292377
• MDR Text Key: 66239404
• Report Number: 9611109-2017-00025
• 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
• Report Date: 02/01/2017

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: 10-88-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2011
• 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