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

Model Number 955626

Device Problems Failure to Cycle (1142); Product Quality Problem (1506); Improper Flow or Infusion (2954)

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

Event Date 05/02/2022

Event Type  malfunction  

Event Description

Nurse changing bag on baxter prismax continuous renal replacement therapy (crrt) system.Crrt machine alarmed "system error." registered nurse (rn) immediately set up for recirculation of blood.Second rn assisted.Machine failed to do machine recruit so rn had to crank blood return.Rn was not able to get full amount of blood back to patient.Rn called 24hr service and they stated to get a work order on it.Manufacturer response for baxter prismax crrt machine, prismax (per site reporter) mayo clinic in arizona has been working closely with baxter including multiple site visits for over two and a half years in an attempt to identify the problems and fix the problems.

Event Description

Nurse changing bag on baxter prismax continuous renal replacement therapy (crrt) system.Crrt machine alarmed "system error." registered nurse (rn) immediately set up for recirculation of blood.Second rn assisted.Machine failed to do machine recruit so rn had to crank blood return.Rn was not able to get full amount of blood back to patient.Rn called 24hr service and they stated to get a work order on it.Manufacturer response for baxter prismax crrt machine, prismax (per site reporter).User facility has been working closely with baxter including multiple site visits for over two and a half years in an attempt to identify the problems and fix the problems.

Event Description

Nurse changing bag on baxter prismax continuous renal replacement therapy (crrt) system.Crrt machine alarmed "system error." registered nurse (rn) immediately set up for recirculation of blood.Second rn assisted.Machine failed to do machine recruit so rn had to crank blood return.Rn was not able to get full amount of blood back to patient.Rn called 24hr service and they stated to get a work order on it.Manufacturer response for baxter prismax crrt machine, prismax (per site reporter).User facility has been working closely with baxter including multiple site visits 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; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 16938041
• MDR Text Key: 315286429
• Report Number: 16938041
• 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: 14600 DA
• Patient Sex: Male
• Patient Weight: 51 KG
• Patient Race: American Indian Or Alaskan Native