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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG 10027#AVALON ELITE 27F, 31CM
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MAQUET CARDIOPULMONARY AG 10027#AVALON ELITE 27F, 31CM Back to Search Results
Model Number 10027#AVALON ELITE
Device Problem Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/15/2015
Event Type  Injury  
Event Description
It was reported that the customer had difficulties placing a dual lumen cannulae in the right internal jugular vein (ij) of a patient who also had a port-a-cath in the right subclavian vein additional information received july 23, 2015: the port-a-cath was obstructing the cannulation.The surgeon spent about an hour attempting to insert the cannula, then switched to fem-fem cannulation and instituted va-ecmo therapy via femoral artery, femoral vein access.The patient was stabilized.No reported patient effect.(b)(4).
 
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Brand Name
10027#AVALON ELITE 27F, 31CM
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
Manufacturer (Section G)
MAQUET MEDICAL SYSTEMS USA
45 barbour pond drive
wayne NJ 07470 0000
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470-0000
MDR Report Key5008140
MDR Text Key23198131
Report Number3008355164-2015-00161
Device Sequence Number1
Product Code DWF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Report Date 08/14/2015,07/15/2015
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 Number10027#AVALON ELITE
Device Catalogue Number70106.3537
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/15/2015
Event Location Hospital
Date Report to Manufacturer07/15/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/14/2015
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 Outcome(s) Required Intervention;
Patient Age35 YR
Patient Weight83
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