MAUDE Adverse Event Report: FRESENIUS USA, INC. 2008® SERIES HEMODIALYSIS MACHINES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190858

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/23/2022

Event Type  malfunction  

Event Description

When the patient was connected to the hemodialysis machine the machine was alarming high conductivity, not reading transmembrane pressure (tmp), and said low flow error. There was an attempt to reset the machine, but due to high pressures that were not reading and no tmp reading the patient's venous site on the left av fistula infiltrated.

• Brand Name: 2008® SERIES HEMODIALYSIS MACHINES
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS USA, INC.; 920 winter street; waltham MA 02451
• MDR Report Key: 13794847
• MDR Text Key: 287332471
• Report Number: 13794847
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 190858
• Device Lot Number: 2008T
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Type of Device Usage: Unkown