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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC
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MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC Back to Search Results
Model Number HMOD 3000
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 12/18/2012
Event Type  Injury  
Event Description
The customer stated that he had changed out two hmod3000 due to clotting within 13 hours of application.According to the customer this is not usual behavior for how they use the hmod30000.The customer stated all coagulation parameters were within normal practice, viz.Act, ptt, antixa, platelet count.Neither sepsis, dic nor hit were diagnosed.The medications being used concurrently were epinephrine, heparin, milrinone.After the initial two complaints were reported, the customer reported three additional complaints.This is complaint 1 of 5.(b)(4).
 
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Brand Name
QUADROX-ID PEDIATRIC
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
MDR Report Key4365132
MDR Text Key5232311
Report Number3008355164-2014-00330
Device Sequence Number1
Product Code DTZ
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 12/17/2014,12/19/2012
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? Yes
Device Operator Health Professional
Device Model NumberHMOD 3000
Device Lot Number770080079
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/24/2012
Event Location Hospital
Date Report to Manufacturer11/26/2012
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/17/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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