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

Lot Number 20DXAC088

Device Problems Fluid/Blood 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.

• Brand Name: NATURALYTE SOLUTION
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): FRESENIUS USA MANUFACTURING, INC.
• MDR Report Key: 10086716
• MDR Text Key: 192170798
• Report Number: MW5094654
• Device Sequence Number: 4
• Product Code: KPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2020
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 20DXAC088
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1