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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS HOMEPUMP C-SERIES ELASTOMERIC PUMP; PUMP, INFUSION, ELASTOMERIC

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AVANOS MEDICAL, INC. AVANOS HOMEPUMP C-SERIES ELASTOMERIC PUMP; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Model Number 5FU C SERIES
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 10/01/2021
Event Type  malfunction  
Event Description
5fu leaking from filter of elastomeric bulb tubing.Small amount of dried white substances noted on outside of line when disconnecting.Lot number 30117472.Pump removed.
 
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Brand Name
AVANOS HOMEPUMP C-SERIES ELASTOMERIC PUMP
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
AVANOS MEDICAL, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key12597712
MDR Text Key275402926
Report Number12597712
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number5FU C SERIES
Device Lot Number30117472
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/06/2021
Event Location Outpatient Treatment Facility
Date Report to Manufacturer10/08/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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