MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX M150 FILTER SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 109990

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 04/01/2021

Event Type  malfunction  

Event Description

Blood alarm went off, blood noted in effluent bag.Fda safety report id# (b)(4).

• Brand Name: PRISMAFLEX M150 FILTER SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 11701677
• MDR Text Key: 246973831
• Report Number: MW5100907
• Device Sequence Number: 1
• Product Code: KDI
• 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: 04/19/2021

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: 109990
• Device Lot Number: 20F0103
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR