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

Model Number LP2

Device Problems Complete Blockage (1094); Device Inoperable (1663)

Patient Problem Thrombus (2101)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

Once device was started it was found to not perform at the full 2.5 lpm; after troubleshooting and speaking with the rep it was determined to have a clot in the device or that the patient was hypovolemic.The patient was given a fluid bolus.This did not correct the issue so the device was removed from the patient and a new one placed, which worked correctly.The device was inspected and the clot was found in the device.The rep stated that the clot most likely was from a clot in the sheath or an unknown lv thrombus.

• 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: 3904336
• MDR Text Key: 4651297
• Report Number: 3904336
• Device Sequence Number: 1
• Product Code: KFM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: LP2
• Device Lot Number: 77801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2014
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 101