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

Catalog Number 112465

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/24/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during priming with one unit of a polyflux 140h, water leakage on the female connector was observed.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H3: the actual sample was not available however, a picture and video were provided for investigation.The visual inspection of the provided photo showed the wet product after use with the product label visible.The visual inspection of the provided video showed the product during use with a dripping visible in the header area.The reported condition was verified.The cause 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
• Manufacturer (Section G): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; holger - crafoord - strasse 26; hechingen D-723 79; GM D-72379
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13003201
• MDR Text Key: 285016735
• Report Number: 9611369-2021-00352
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414102753
• UDI-Public: (01)07332414102753
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 112465
• Device Lot Number: 1-5801-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1