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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY MAQUET INTRA-AORTIC BALLOON CATHETER

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MAQUET CARDIOPULMONARY MAQUET INTRA-AORTIC BALLOON CATHETER Back to Search Results
Lot Number (21) CH256995E7
Device Problems Backflow (1064); Device Contamination with Body Fluid (2317)
Patient Problem Pain (1994)
Event Date 12/14/2017
Event Type  malfunction  
Event Description
Pt. Waiting on a heart transplant. Bedside rn noticed iabp waveform changed, flushed line and waveform returned momentarily. Waveform again changed and when rn assessed the helium tubing, she found condensation and small specks of blood in the line. Ccu team was called to the bedside and at this time the amount of blood in the tubing increased. Iabp was put in standby and helium tubing clamped. Pt reporting pain. Ct surgery team came to assess pt. Balloon was removed. Repair r axillary artery.
 
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Brand NameMAQUET
Type of DeviceINTRA-AORTIC BALLOON CATHETER
Manufacturer (Section D)
MAQUET CARDIOPULMONARY
45 barbour pond dr
wayne NJ 07470
MDR Report Key9255352
MDR Text Key164282078
Report Number9255352
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number(21) CH256995E7
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/10/2019
Event Location Hospital
Date Report to Manufacturer10/30/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/30/2019 Patient Sequence Number: 1
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