MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION M100 FILTER; DIALYZER, HIGH PERMEABILITY, DIALYSATE SYSTEM

Lot Number 1881203

Device Problem Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 06/01/2018

Event Type  Injury  

Event Description

M100 crrt deaeration chamber found to have pieces of fiberglass looking material clogging the chamber.Color and consistency similar to filter material.Concern raised regarding materials migrating to pt.Crrt therapy was interrupted/restarted to change the filter and tubing.Nephrology was notified of the issue and order to change filter size to m150 promptly.

• Brand Name: M100 FILTER
• Type of Device: DIALYZER, HIGH PERMEABILITY, DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 7586525
• MDR Text Key: 110746689
• Report Number: MW5077728
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1881203
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR