MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number M100

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/10/2022

Event Type  malfunction  

Event Description

Elderly female with history of previous cardiovascular accident's (cva/stroke) and new onset altered mental status and urinary tract infection.Procedure: dialysis with prismaflex kidney.When the package for the baxter, prismaflex m100 set was opened, the filter portion of the kidney is completely broken off from the rest of the kidney.Not used on the patient.Stored flat on shelf in packaging prior.Manufacturer response for dialyzer, high permeability with or without sealed dialysate system, prismaflex set (per site reporter).Will obtain.

• Brand Name: PRISMAFLEX SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO INDUSTRIES; one baxter parkway; deerfield IL 60015
• MDR Report Key: 14436006
• MDR Text Key: 292046527
• Report Number: 14436006
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414064556
• UDI-Public: (01)07332414064556(11)210901(17)230831(10)2113001CA
• 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: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M100
• Device Catalogue Number: 106697
• Device Lot Number: 2113001CA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Female
• Patient Weight: 104 KG