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U.S. Department of Health and Human Services

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

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AVANOS MEDICAL, INC. AVANOS HOMEPUMP C; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Lot Number 0203095772
Device Problems Leak/Splash (1354); Failure to Infuse (2340)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Pump was connected to patient, inadvertently clamped for 48 hours.The pump was unclamped but did not infuse.Difficult to tell if this was due to pump malfunction or medication crystallization.Another pump from this lot leaked.This lot was sequestered by (b)(6) and new lot distributed, to err on the side of caution.Fda safety report id# (b)(4).
 
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Brand Name
AVANOS HOMEPUMP C
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
AVANOS MEDICAL, INC.
alpharetta GA 30004
MDR Report Key10042977
MDR Text Key190669345
Report NumberMW5094438
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/07/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received05/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/15/2021
Device Lot Number0203095772
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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