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

Model Number IMPELLA 5.0

Device Problems Disconnection (1171); Device Inoperable (1663)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 05/29/2018

Event Type  malfunction  

Event Description

Patient was ambulating back to bed from the chair when the impella power cord came disconnected at the red/grey connector site with arrows.Staff noticed right away, informed the patient's nurse and quickly reconnected the two connections - however when interviewed after the event the staff was not absolutely certain that the arrows were aligned.The patient was placed into bed and his pressure immediately began to drop, requiring titration of his pressors.Upon assessment by the team, the impella was not working.The patient continued to decline and ultimately patient was intubated and cannulated for ecmo as a result of the impella not functioning as intended and staff inability to find a solution in the moment.

• Brand Name: IMPELLA
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• MDR Report Key: 7645251
• MDR Text Key: 112617560
• Report Number: 7645251
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IMPELLA 5.0
• Device Lot Number: 155522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA