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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABIOMED IMPELLA HEART PUMP
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ABIOMED IMPELLA HEART PUMP Back to Search Results
Model Number 0048-003
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Cardiogenic Shock (2262)
Event Date 01/05/2018
Event Type  Injury  
Event Description
Impella heart pump was inserted on (b)(6) 2018 into a pt suffering from shock after a stemi.The device began alarming (b)(6) 2018, cardiologist and rep from abiomed attempted to troubleshoot the alarms in the cvicu without success.The pt was transported to the cardiac cath lab for possible repositioning and or reinsertion.Abiomed rep remained assisted troubleshooting in cardiac cath lab.A new device was inserted.The original device was removed in fluoro guidance and the pt was transported back in cvicu.The abiomed rep retained the original device for reimbursement and investigation purposes.Dates of use: (b)(6) 2018.Diagnosis or reason for use: cardiogenic shock s/p stemi.
 
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Brand Name
IMPELLA HEART PUMP
Type of Device
IMPELLA HEART PUMP
Manufacturer (Section D)
ABIOMED
MDR Report Key7181755
MDR Text Key97084088
Report NumberMW5074532
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0048-003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/10/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
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