MAUDE Adverse Event Report: ST. JUDE MEDICAL/ THORATEC CORP. HEARTMATE II; VENTRICULAR (ASSISST) BYPASS

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Date 01/04/2017

Event Type  malfunction  

Event Description

St.Jude heartmate ii implantable pump was being primed for surgery and noted a jet with bubbles expelled from the motor while completely submerged under saline for 6 min.These jets expelled bubbles 2 more times while priming the pump.Discussed with doctor, and st.Jude representative returned the pump to the manufacturer and primed a new pump.At no point did the pump enter the patient's body.

• Brand Name: HEARTMATE II
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): ST. JUDE MEDICAL/ THORATEC CORP.; 23 4th ave.; burlington MA 01803
• MDR Report Key: 6417247
• MDR Text Key: 70359344
• Report Number: 6417247
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2017
• Event Location: Other
• Date Report to Manufacturer: 02/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other