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

Model Number IMPELLA 5.0

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 08/03/2014

Event Type  malfunction  

Event Description

Surgeon checked function of impella 5.0 device and found it would not function.
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manufacturer response for impella 5.0 device, impella 5.0 (per site reporter).
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rm spoke to manufacturer's rep.He advises it may take as long as 8-10 to have the device analyzed and reported upon.

• 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: 4173621
• MDR Text Key: 5158743
• Report Number: 4173621
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: IMPELLA 5.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 72 YR