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

Model Number 955626

Device Problems Defective Component (2292); Pressure Problem (3012)

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

Event Date 04/25/2023

Event Type  malfunction  

Event Description

Continuous renal replacement therapy (crrt) machine alarmed for excessively negative return pressure as if the patient had been disconnected from the machine, patient remained connected however.Alarm would not resolve, then suddenly alarmed for filter pressure despite the filter being brand new and having just been changed 10 minutes prior.Unable to return blood.227 blood remained in the filter.Hemoglobin (hgb), on labs following event, showed no change in hgb level.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: 17030373
• MDR Text Key: 316217537
• Report Number: 17030373
• 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
• Report Date: 05/15/2023

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: 05/15/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2023
• 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: 22630 DA
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Race: White