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); Air/Gas in Device (4062)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/31/2021

Event Type  malfunction  

Event Description

The continuous renal replacement therapy (crrt) machine detected extreme negative pressure on the return line.The machine promptly stopped the therapy itself.Therapy resumed immediately after assessing patient and ensuring lines and machine was properly secured.Upon resumption, crrt machine repeated the same negative pressure alarm on the return line.Approximately a minute afterwards, the deaeration chamber began to pull down the fluid more aggressively.This then led to the crrt machine stopping indefinitely due to detected clot/air in the deaeration chamber.No clot or air was sent to the patient.Unable to return blood back to the patient.Patient remained stable.Critical care team notified.Orders received to restart crrt.Manufacturer response for baxter prismax crrt machine, prismax (per site reporter) mayo clinic arizona has been working with baxter for over two years with multiple on-site visits to correct the machine malfunction without success.

Event Description

The continuous renal replacement therapy (crrt) machine detected extreme negative pressure on the return line.The machine promptly stopped the therapy itself.Therapy resumed immediately after assessing patient and ensuring lines and machine was properly secured.Upon resumption, crrt machine repeated the same negative pressure alarm on the return line.Approximately a minute afterwards, the deaeration chamber began to pull down the fluid more aggressively.This then led to the crrt machine stopping indefinitely due to detected clot/air in the deaeration chamber.No clot or air was sent to the patient.Unable to return blood back to the patient.Patient remained stable.Critical care team notified.Orders received to restart crrt.Manufacturer response for baxter prismax crrt machine, prismax (per site reporter).User facility has been working with baxter for over two years with multiple on-site visits to correct the machine malfunction without success.

Event Description

The continuous renal replacement therapy (crrt) machine detected extreme negative pressure on the return line.The machine promptly stopped the therapy itself.Therapy resumed immediately after assessing patient and ensuring lines and machine was properly secured.Upon resumption, crrt machine repeated the same negative pressure alarm on the return line.Approximately a minute afterwards, the deaeration chamber began to pull down the fluid more aggressively.This then led to the crrt machine stopping indefinitely due to detected clot/air in the deaeration chamber.No clot or air was sent to the patient.Unable to return blood back to the patient.Patient remained stable.Critical care team notified.Orders received to restart crrt.Manufacturer response for baxter prismax crrt machine, prismax (per site reporter).User facility has been working with baxter for over two years with multiple on-site visits to correct the machine malfunction without success.

• 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: 16938249
• MDR Text Key: 315286294
• Report Number: 16938249
• 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
• Device Age: 1 YR
• 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: 22995 DA
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White