MAUDE Adverse Event Report: ABIOMED IMPELLA CP, PERCUTANEOUS HEART PUMP

Model Number IMPELLA CP

Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)

Patient Problem Chest Pain (1776)

Event Date 01/24/2017

Event Type  Injury  

Event Description

Impella cp was inserted in cath lab room 04 and started at 15:47.Impella cp flows only went up to 0.9 to 1.0lpm on auto.Another impella cp was opened and started at 15:57 second impella cp was successful.The malfunctioned impella cp pump was saved & will be sent back to the company, abiomed.Diagnosis or reason for use: chest pain with moderate risk of acute coronary syndrome.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: IMPELLA CP, PERCUTANEOUS HEART PUMP
• Type of Device: IMPELLA CP, PERCUTANEOUS HEART PUMP
• Manufacturer (Section D): ABIOMED; danvers MA 01923
• MDR Report Key: 6297833
• MDR Text Key: 66503577
• Report Number: MW5067618
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 102