MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 210H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 955610

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) # reported as: (b)(4).Initial reporter facility name: (b)(6) medical center.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported before priming, a green foreign matter was observed inside the housing of a polyflux 210h.There was no patient involvement associated with the reported event.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.Visual inspection with the naked eye showed that the product wet.A green particulate was observed on the fibre bundle.The reported failure was verified.The material analysis of the particulate matter showed that the material was polypropylen.The most likely cause for the green particle is a defective transport box in production.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: POLYFLUX 210H
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11140758
• MDR Text Key: 227025223
• Report Number: 9611369-2020-00203
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 955610
• Device Lot Number: 9-5576-H-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1