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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID
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MAQUET CARDIOPULMONARY AG QUADROX-ID Back to Search Results
Model Number HMOD7000-USA
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Event Description
It was reported that during the use of an oxygenator a nurse initially noticed a few drops of blood.Some time passed and more blood was observed on the floor.Upon inspection of the oxygenator, a steady flow of blood from the arterial outlet was detected.The facility reported that the leak was not on the port, but the housing perpendicular to the flow and possibly along a seam.While replacing the oxygenator the arterial outlet disconnect.The oxygenator was successfully replaced, no patient injury was reported.Manufacturer previously submitted initial mfg.Report #8010762-2012-00054.(b)(4).
 
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Brand Name
QUADROX-ID
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
MDR Report Key4365169
MDR Text Key21329934
Report Number3008355164-2014-00353
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 12/16/2014,11/24/2012
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? No
Device Operator Health Professional
Device Expiration Date02/01/2013
Device Model NumberHMOD7000-USA
Device Catalogue Number70105.3815
Device Lot Number70062354
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date11/24/2012
Device Age22 MO
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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