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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET MAQUET QUADROX OXYGENATOR
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MAQUET MAQUET QUADROX OXYGENATOR Back to Search Results
Lot Number 3000009934
Device Problems Occlusion Within Device (1423); Device Displays Incorrect Message (2591)
Patient Problems Anoxia (1711); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)
Event Date 07/10/2015
Event Type  Injury  
Event Description
Pt was placed on v-a ecmo support using quadrox oxygenator at 0647 on (b)(6) 2015.By 1500 that same day the console was alarming low flow, greater than 1l.After troubleshooting for a few minutes, it was decided to change out the ecmo circuit.Once the circuit was changed out, including the oxygenator, flow was once again re-established.The oxygenator that was removed was tested to see if there were any clots inside and it was found that no blood or saline could be flushed through the oxygenator.There was complete failure of the oxygenator to allow anything through the membrane.Because of this failure, the pt went several minutes without flow, was hypoxic and hypotensive/and suffered anoxia.Care was withdrawn the next day.Dates of use: (b)(6) 2015 and (b)(6) 2015.Reason for use: cardiogenic shock and ecmo.
 
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Brand Name
MAQUET QUADROX OXYGENATOR
Type of Device
QUADROX OXYGENATOR
Manufacturer (Section D)
MAQUET
MDR Report Key4960159
MDR Text Key6194832
Report NumberMW5044974
Device Sequence Number1
Product Code DTZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2017
Device Lot Number3000009934
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2015
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age31 YR
Patient Weight115
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