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

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 08/11/2020

Event Type  malfunction  

Event Description

Top of m150 prismaflex filter became disconnected from crrt.Pressure alarm sounded.Crrt machine stopped by nursing, filter removed from machine, minimal bloodloss.Fda safety report id# (b)(4).

• Brand Name: M150 PRISMAFLEX FILTER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 10477303
• MDR Text Key: 205341827
• Report Number: MW5096355
• 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: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR