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U.S. Department of Health and Human Services

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Type of Device:
TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
Device Brand Name:
Impella CP
Device Manufacturer's Name:
Abiomed, Inc.
Date of this Report:
(mm/dd/yyyy)
09/11/2018
Describe the Event
or Problem:
Pump 1 had flows less than expected. Material was found in the pump. It's currently being soaked in solution to remove and determine what the material is. Pump 2 did not start. The pump housing/outlet cage and impeller were crushed. Engineers are determining how this could have occurred. This is the first time this occurred within last year. I have heard of past problems after f/u with Cardiac Cath manager.
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Manufacturer response for Impella, (brand not provided) (per site reporter)
======================
The two Impella pumps that were used during the recent case were returned to Abiomed. I spoke with one of our Engineers yesterday. Their initial finding were: Pump 1. Had flows less than expected. Material was found in the pump. It's currently being soaked in solution to remove and determine what the material is. Pump 2. Did not start. The pump housing / outlet cage and impeller were crushed. Engineers are determining how this could have occurred.
======================
Manufacturer response for Impella, Impella (per site reporter)
======================
The two Impella pumps that were used during the recent case were returned to Abiomed. I spoke with one of our Engineers yesterday. Their initial finding were: Pump 1. Had flows less than expected. Material was found in the pump. It's currently being soaked in solution to remove and determine what the material is. Pump 2. Did not start. The pump housing / outlet cage and impeller were crushed. Engineers are determining how this could have occurred.
the device(s) may have
caused or contributed to:
Death
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