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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX LLC (NADC 2) INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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TELEFLEX LLC (NADC 2) INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problem Increase in Pressure (1491)
Patient Problem Insufficient Information (4580)
Event Date 08/18/2021
Event Type  malfunction  
Event Description
This is a good catch. Bedside nurse attended to iabp alarmed high pressure. Blood present in tubing. Cardiology contacted. Patient taken to cardiac cath lab, iabp removed and a new one placed in opposite femoral artery. Fda safety report id # (b)(4).
 
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Brand NameINTRA-AORTIC BALLOON PUMP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX LLC (NADC 2)
MDR Report Key12438703
MDR Text Key270680860
Report NumberMW5103756
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/07/2021 Patient Sequence Number: 1
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