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

Model Number 955626

Device Problems Product Quality Problem (1506); No Flow (2991); Noise, Audible (3273); Unexpected Shutdown (4019); Air/Gas in Device (4062)

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

Event Date 12/11/2021

Event Type  malfunction  

Event Description

Baxter prismax continuous rental replacement therapy (crrt) system alarmed air detected.Registered nurse (rn) troubleshooted per prismax instruction, during troubleshoot crrt shutdown and began making high pitched noise.Unable to return blood to patient.New crrt machine to be primed and connected to patient for therapy, complete blood count to be drawn now.Patient remained hemodynamically stable.Air was never present in line, only in deaeration chamber.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

Baxter prismax continuous rental replacement therapy (crrt) system alarmed air detected.Registered nurse (rn) troubleshooted per prismax instruction, during troubleshoot crrt shutdown and began making high pitched noise.Unable to return blood to patient.New crrt machine to be primed and connected to patient for therapy, complete blood count to be drawn now.Patient remained hemodynamically stable.Air was never present in line, only in deaeration chamber.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

Baxter prismax continuous rental replacement therapy (crrt) system alarmed air detected.Registered nurse (rn) troubleshooted per prismax instruction, during troubleshoot crrt shutdown and began making high pitched noise.Unable to return blood to patient.New crrt machine to be primed and connected to patient for therapy, complete blood count to be drawn now.Patient remained hemodynamically stable.Air was never present in line, only in deaeration chamber.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: 16938072
• MDR Text Key: 315291573
• Report Number: 16938072
• 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: 17155 DA
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Race: White