MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 140H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 112465

Device Problem Leak/Splash (1354)

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

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that after 10 minutes of treatment with three units of polyflux 140h dialyzer, an external blood leak was observed.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of two of the provided photos shows the product during the treatment and do not show blood on the dialysate side (internal blood leak) or blood outside the product (external blood leak).The third photo shows the product can be seen after the treatment and without blood.The reported event was not verified.The cause of the condition could not be determined.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 140H
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11475162
• MDR Text Key: 244945117
• Report Number: 9611369-2021-00040
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414102753
• UDI-Public: (01)07332414102753
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• 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: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 112465
• Device Lot Number: 0-5819-H-02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1