MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/10/2018

Event Type  malfunction  

Event Description

Impella alarmed "impella stopped retrograde flow." attempted to change to different controller per troubleshooting instructions on impella controller, same alarm on new controller, the icu team removed the impella device and the arterial sheath.The impella rep was notified and at the bedside post removal.

• Brand Name: IMPELLA
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• MDR Report Key: 7525250
• MDR Text Key: 108618514
• Report Number: 7525250
• 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: Other
• Type of Report: Initial
• Report Date: 05/15/2018,05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: SN154672
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR