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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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MAQUET CARDIOVASCULAR CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Device Problems High Test Results (2457); Device Operates Differently Than Expected (2913)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 01/20/2018
Event Type  malfunction  
Event Description
An ecmo circuit change was initiated for a high plasma free hemoglobin.The new pump had a -37 servo pressure which was where the patient had been.The patient became hypotensive and ecmo flows were increased and servo pressure remained -37.The venous line was also clamped with no change in servo pressure.A pressure transducer was added to the venous side of the bridge that measured -25 and responded appropriately to increase and decrease in flows.The alarm was set for -30 while trouble shooting.Consult with leaders and maquet representative.The circuit was changed again without further issue related to the cardiohelp.
 
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Brand Name
CARDIOHELP
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOVASCULAR
45 barbour pond drive
wayne NJ 07470
MDR Report Key7334008
MDR Text Key102219693
Report Number7334008
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/22/2018,03/06/2018
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
Other Device ID Number238598
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/22/2018
Event Location Hospital
Date Report to Manufacturer02/22/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
CARDIAC DRUGS; PATIENT WAS ON ECMO CIRCUIT.
Patient Age10 YR
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