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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HOME PUMP C SET, ADMINISTRATION, INTRAVASCULAR

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AVANOS MEDICAL, INC. HOME PUMP C SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 0203095772
Device Problem Failure to Infuse (2340)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2019
Event Type  malfunction  
Event Description
Pump did not infuse chemo agent. Fda safety report id# (b)(4).
 
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Brand NameHOME PUMP C
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
AVANOS MEDICAL, INC.
alpharetta GA
MDR Report Key8949865
MDR Text Key156322627
Report NumberMW5089472
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0203095772
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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