MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 17L; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 109650

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that after two hours of treatment with a polyflux17l, an external fluid leak (dialysate) was observed from the header.It was reported the patient experienced a blood loss of 200ml.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the actual device was not returned for evaluation, however a photo was provided.Visual inspection of the provided photo showed the product after treatment and only the product label was visible.Neither the failure nor the cause for the failure was visible.Due to the absence of an actual sample, the cause of the reported problem 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 17L
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11047781
• MDR Text Key: 227027780
• Report Number: 9611369-2020-00194
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414086626
• UDI-Public: (01)07332414086626
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 109650
• Device Lot Number: 0-4214-H-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1