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

Device Problems Device Sensing Problem (2917); Priming Problem (4040)

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

Event Date 05/15/2023

Event Type  malfunction  

Event Description

While priming a new crrt m150 filter on a prismax, a warning screen kept popping up stating "blood leak detector normalization failed".The interventions for this were to check the effluent tubing for air in the line, which there was none, and then to reprime with another 2l of ns.This was attempted for a total of 6l ns; without resolution of error.At that point, i called baxter's icon help line and spoke to representative.Representative advised me to try and override the warning screen by checking the internal measurements.The blood leak detector was showing at 0%, so representative determined that the sensor of the bld was malfunctioning.Representative said i could attempt to try a new filter but that it would probably be better to switch out machines and send the current prismax down to be serviced.Manufacturer response for baxter prismax crrt machine, prismax (per site reporter).User error.

• Brand Name: PRISMAX
• 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: 17208198
• MDR Text Key: 317934499
• Report Number: 17208198
• 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: 06/12/2023

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
• 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: 06/12/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Hispanic
• Patient Race: White