MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 7.20

Device Problems Display or Visual Feedback Problem (1184); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2023

Event Type  malfunction  

Event Description

New set primed, error reading "malfunction effluent line blood dector" no way to clear error.Icon 1-800 number called.Prismaflex representative stated this is a machine malfunction with no way to fix.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS, INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16794768
• MDR Text Key: 313816651
• Report Number: 16794768
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2023

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 Model Number: 7.20
• Device Catalogue Number: 955542
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Female