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

Catalog Number	104176
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during preparation with two units of polyflux 21 l, a crack and leaking solution "on top" was observed.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: POLYFLUX
• Common Device Name: 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 60073 ; 2242702068
• MDR Report Key: 16498279
• Report Number: 9611369-2023-00027
• Device Sequence Number: 6366877
• Product Code: KDI
• UDI-Device Identifier: 07332414048181
• UDI-Public: (01)07332414048181
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K043342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: 104176
• Device Lot Number: 1-6034-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 04/12/2023
• Date Device Manufactured: 12/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown