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

Model Number 955626

Device Problems Pressure Problem (3012); Unexpected Shutdown (4019)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/20/2021

Event Type  malfunction  

Event Description

Upon troubleshooting a "negative pressure" alarm on prismax system, silence button was pressed and machine suddenly turned off.Upon turning it back on, filter sets had to be discarded and treatment restarted on a "new patient" ¿ therefore unable to return the blood prior to filter change, etc.Prismax system and filter changes took approximately one hour, time of which patient did not receive continuous renal replacement therapy (crrt).Manufacturer response for baxter prismax crrt machine, prismax (per site reporter) mayo clinic in arizona has been working closely with baxter for over two and a half years in an attempt to identify the problems and fix the problems.

Event Description

Upon troubleshooting a "negative pressure" alarm on prismax system, silence button was pressed and machine suddenly turned off.Upon turning it back on, filter sets had to be discarded and treatment restarted on a "new patient" ¿ therefore unable to return the blood prior to filter change, etc.Prismax system and filter changes took approximately one hour, time of which patient did not receive continuous renal replacement therapy (crrt).Manufacturer response for baxter prismax crrt machine, prismax (per site reporter).User facility has been working closely with baxter for over two and a half years in an attempt to identify the problems and fix the problems.

Event Description

Upon troubleshooting a "negative pressure" alarm on prismax system, silence button was pressed and machine suddenly turned off.Upon turning it back on, filter sets had to be discarded and treatment restarted on a "new patient" ¿ therefore unable to return the blood prior to filter change, etc.Prismax system and filter changes took approximately one hour, time of which patient did not receive continuous renal replacement therapy (crrt).Manufacturer response for baxter prismax crrt machine, prismax (per site reporter).User facility has been working closely with baxter for over two and a half years in an attempt to identify the problems and fix the problems.

• 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: 16938222
• MDR Text Key: 315288876
• Report Number: 16938222
• 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: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2023

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 Operator: Health Professional
• Device Model Number: 955626
• Device Catalogue Number: 955626
• 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: 05/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/22/2023; 05/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24455 DA
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Race: Native Hawaiian Or Other Pacific Islander