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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOHELP-I SYSTEM
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MAQUET CARDIOPULMONARY AG MAQUET CARDIOHELP-I SYSTEM Back to Search Results
Model Number 70104.8012
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Meningitis (2389)
Event Date 02/19/2014
Event Type  Death  
Event Description
It was reported that a patient was placed on the cardiohelp with meningitis which created cardiac failure.The initiation of ecls (extracorporeal life support) was successful but there was difficulty maintaining sufficient flow.The initial flows were 1.5 liters/min but soon dropped to 200-400 mls/min at 3000 rpm's.The cannulas appeared to be very small and the patient's volume was deficient.The venous pressures had a very high negative reading while the arterial pressure was normal.The death is attributed to the patient's poor condition and not the device.No device malfunction was reported.(b)(4).Ref mfr report 8010762-2014-00146.
 
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Brand Name
MAQUET CARDIOHELP-I SYSTEM
Type of Device
CARDIOHELP-I SYSTEM
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
MDR Report Key3720407
MDR Text Key15200427
Report Number3008355164-2014-00061
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 Distributor
Source Type Unknown
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/20/2014,02/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number70104.8012
Device Catalogue Number70104.8012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/19/2014
Event Location Hospital
Date Report to Manufacturer02/23/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/02/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age13 YR
Patient Weight50
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