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

Model Number M150

Device Problem Backflow (1064)

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

Event Date 03/01/2023

Event Type  malfunction  

Event Description

Stopped crrt(continuous renal replacement therapy) to return blood and change the set.Connected the set to return blood and noticed that there was blood in the effluent and prismaflex bags/lines.No blood was returned to the patient and set was immediately removed.Patient stable and no change.New set and machine reset.

• Brand Name: PRISMAFLEX FILTER AND PRISMAX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 16590256
• MDR Text Key: 311840451
• Report Number: MW5115900
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/20/2023

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: M150
• Device Catalogue Number: 109990
• Device Lot Number: 22C0062CB
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2023
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male