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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC OXYGENATOR; DTZ

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MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC OXYGENATOR; DTZ Back to Search Results
Device Problem Occlusion Within Device (1423)
Patient Problem Sepsis (2067)
Event Date 09/29/2012
Event Type  Injury  
Event Description
Oxygenator developed clots and failed to work.Had to be changed out four times.(b)(6) unstable during change out.Patient e-coli sepsis.(b)(4).The customer reported it changed out the unit 4 times.This device is 4 of 4.
 
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Brand Name
QUADROX-ID PEDIATRIC OXYGENATOR
Type of Device
DTZ
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
Manufacturer (Section G)
MAQUET MEDICAL SYSTEMS USA
45 barbour pond drive
wayne NJ 07470 000
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470-0000
MDR Report Key4365098
MDR Text Key18641836
Report Number3008355164-2014-00376
Device Sequence Number1
Product Code DTZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/17/2014,10/01/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/01/2012
Event Location Hospital
Date Report to Manufacturer10/01/2012
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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