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
• UDI-Device Identifier: 00840861100903
• UDI-Public: (01)00840861100903
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190858
• Device Lot Number: 2008T
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 7665 DA
• Patient Sex: Female