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

Device Problems Protective Measures Problem (3015); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 08/18/2022

Event Type  malfunction  

Event Description

Crrt (continuous renal replacement therapy) machine read alarm "gain limit reached" and would not allow for the blood to be returned to the patient at this time.Doctor notified immediately.Risk closure comments: nursing operations manager ip (infection preventionist) explained to ce tech that this is a safety issue: gain limit reached, this is supposed to happen to the machine.Machine worked properly, no further action needed by clinical engineering.

• Brand Name: PRISMAFLEX
• 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: 17305087
• MDR Text Key: 318847086
• Report Number: 17305087
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1