MAUDE Adverse Event Report: SORIN GROUP USA INC., CARDIOPULMONARY AND HEART VALVE BUSINESS UNITS STOCKERT; BLOOD PUMP

Model Number RIGHT PUMP S5 ROLLER PUMP 150

Device Problems Component(s), broken (1103); Device Issue (2379)

Patient Problems Anoxia (1711); Death (1802); Aortic valve replacement (2472)

Event Date 11/15/2014

Event Type  Death  

Event Description

While the patient was connected to the machine, when the roller head began to work intermittent and stopped.Moved to the second head which did the same as the first.Moved to the third which did also stop working.The arterial head turned off but could be turned back on for a few seconds.Then all sorts of alarms that nobody had evernseen started alarming.The anesthesiologist began hand cranking.It was relieved by many.The machine was eventually changed out.

• Brand Name: STOCKERT
• Type of Device: BLOOD PUMP
• Manufacturer (Section D): SORIN GROUP USA INC., CARDIOPULMONARY AND HEART VALVE BUSINESS UNITS; 14401 w 65th way; aruada CO 80004 350
• MDR Report Key: 4352918
• MDR Text Key: 5220333
• Report Number: 4352918
• Device Sequence Number: 3
• Product Code: DTQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/24/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RIGHT PUMP S5 ROLLER PUMP 150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/24/2014
• Distributor Facility Aware Date: 11/15/2014
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Weight: 98