MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA CP; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Device Problems Unintended Power Up (1162); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 03/18/2022

Event Type  malfunction  

Event Description

Perfusion note- per discussion with abiomed representative, impella pump showing signs of strain/possible impending pump failure (increasing motor current, narrowing min/max flow range).Pt now going today for impella cp exchange in or or cath lab due to impending failure of device.Abiomed rep aware - is also aware of other event over the weekend where pt had code 4 event following apparent device malfunction.Cath lab or where device is exchanged has been asked to save device; abiomed rep will take on behalf of company for internal investigation.Able to get impella sn off controller screen as well as controller device number.Per abiomed rep, there is not a lot number available.This patient was a transfer from an outside hospital where the device was placed.Patient then transferred to this hospital for transplant or lvad consideration.

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• MDR Report Key: 14885134
• MDR Text Key: 295147718
• Report Number: 14885134
• Device Sequence Number: 1
• Product Code: QOC
• 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: 03/23/2022

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: Lay User/Patient
• 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: 03/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23725 DA
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Race: White