MAUDE Adverse Event Report: ABIOMED IMPELLA CP

Catalog Number 0048-0003

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 10/14/2016

Event Type  malfunction  

Event Description

"low purge pressure" alarm requiring removal and re-insertion of new product.

• Brand Name: IMPELLA CP
• Type of Device: IMPELLA CP
• Manufacturer (Section D): ABIOMED; danvers MA 01923
• MDR Report Key: 6224972
• MDR Text Key: 64038848
• Report Number: MW5067045
• Device Sequence Number: 1
• Product Code: KFM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1247056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 89