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

Model Number 955626

Device Problems No Display/Image (1183); Self-Activation or Keying (1557); Unexpected Shutdown (4019)

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

Event Date 09/02/2022

Event Type  malfunction  

Event Description

Crrt machine alarmed that bags were empty.I went in to change the bags and after changing the first one, the machine shut down and the screen went black.I immediately clamped the patient's catheter to prevent anything from happening.The machine then turned back on by itself and read "post shutdown error" and would not continue past that screen.Baxter 24/7 number called and representative instructed to shut down machine and manually disconnect patient, which was then done.Representative said it was an internal system error and to take machine out of use.

Event Description

Crrt machine alarmed that bags were empty.I went in to change the bags and after changing the first one, the machine shut down and the screen went black.I immediately clamped the patient's catheter to prevent anything from happening.The machine then turned back on by itself and read "post shutdown error" and would not continue past that screen.Baxter 24/7 number called and representative instructed to shut down machine and manually disconnect patient, which was then done.Representative said it was an internal system error and to take machine out of use.

• Brand Name: PRISMAXPRISMAX SYSTEM
• 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: 15498342
• MDR Text Key: 300738748
• Report Number: 15498342
• 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,Followup
• Report Date: 09/19/2022

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 Model Number: 955626
• Device Catalogue Number: 955626
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Sex: Female