MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA; PUMP, BLOOD, CARDIOPULMONARY BYPASS

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2017

Event Type  malfunction  

Event Description

The low purge pressure alarm on the impella device could not be resolved.The impella was removed from the patient and a new impella device was inserted with no additional issues reported.The manufacturer's representative was present in the operating room (or) and aware of the issue.There is no known patient injury.

• Brand Name: IMPELLA
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• MDR Report Key: 6405546
• MDR Text Key: 69966313
• Report Number: 6405546
• Device Sequence Number: 1
• Product Code: KFM
• 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: Patient
• Type of Report: Initial
• Report Date: 03/03/2017

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR