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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET / DATASCOPE CORP. IABP-IBA MAQUET 8 F IAB MEGA 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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MAQUET / DATASCOPE CORP. IABP-IBA MAQUET 8 F IAB MEGA 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 30134
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2020
Event Type  malfunction  
Event Description
The existing balloon pump had been inserted on (b)(6) 2020.The machine was alarming on arrival to icu, the perfusionist did some troubleshooting with the machine.We contacted the surgeon, an x-ray was obtained.On arrival to the operating room, there was blood in the balloon pump catheter per the perfusionist and the surgeon was again notified of the new development.A new balloon pump catheter was obtained and was inserted in sterile fashion due to the failure of the existing pump.Failed catheter was passed off and given to operating room/ cvor coordinator, then it went to risk management.Fda safety report id # (b)(4).
 
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Brand Name
IABP-IBA MAQUET 8 F IAB MEGA 50CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
MAQUET / DATASCOPE CORP.
MDR Report Key10118662
MDR Text Key194169731
Report NumberMW5094834
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
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 06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number30134
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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 Age70 YR
Patient Weight69
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