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

Lot Number 378794

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Exsanguination (1841)

Event Date 08/01/2022

Event Type  Death  

Event Description

Patient undergoing cabg (coronary artery bypass graft) when it was noted the patient was bleeding from impella.Blood was dripping under drapes down onto floor.Staff member noticed blood around feet and told surgeon.Patient hypotensive.Patient had significant blood loss before it was recognized impella had crack in it.Patient expired.Fda safety report id# (b)(4).

• Brand Name: IMPELLA
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): ABIOMED, INC.; danvers MA 01923
• MDR Report Key: 15241442
• MDR Text Key: 298059479
• Report Number: MW5111503
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 378794
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White