MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 7.20

Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2022

Event Type  malfunction  

Event Description

Continuous renal replacement therapy (crrt) machine is running a dialysis treatment the screen showed a "download error" message and it stop treatment and cannot continue per bedside nurse.Crrt machines typically run up to 3-5 days of continuous dialysis.Prior to the fatal "download error" message machine has "stable access and circuit pressure" per previous days rounding report.Crrt machine needs to be troubleshooted by biomed to study cause of and to prevent another "download error" message.Summary of work notes from biomed: start troubleshooting by performing a boot-up o.K.Contact tech support.Learn from him that 'download errors' are rare, and there shouldn't be errors during treatment because use of the card only occurs after or before treatment, with one caveat.If the card is full, which very seldom happens because it has a large capacity, a download error could occur.This is a machine that we acquired from stanford and it is relatively old, so it is possible that the card is full.Pending repair of the device is stored in lock-out/tag-out status.There was no harm in this event.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 13558604
• MDR Text Key: 285818132
• Report Number: 13558604
• 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: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• 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: 02/11/2022
• Date Report to Manufacturer: 02/18/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2555 DA
• Patient Sex: Female