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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS USA MANUFACTURING, INC. NATURALYTE SOLUTION DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

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FRESENIUS USA MANUFACTURING, INC. NATURALYTE SOLUTION DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) Back to Search Results
Lot Number 20DXAC088
Device Problems Fluid Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/19/2020
Event Type  malfunction  
Event Description
Fresenius naturalyte solution lot number 20dxac088 found with pinholes on top of seal of solution and leaking. Thrown out affected jugs; 5 in total. Storeroom made aware to check all in storeroom.
 
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Brand NameNATURALYTE SOLUTION
Type of DeviceDIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
Manufacturer (Section D)
FRESENIUS USA MANUFACTURING, INC.
MDR Report Key10086716
MDR Text Key192170798
Report NumberMW5094654
Device Sequence Number1
Product Code KDI
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 05/21/2020
5 Devices were Involved in the Event: 1   2   3   4   5  
0 Patients were Involved in the Event:
Date FDA Received05/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number20DXAC088
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2020
Is the Reporter a Health Professional? No Answer provided
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?
Type of Device Usage

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