MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 170H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	103579
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported during patient treatment with a polyflux 170h set, an external fluid leak was observed.It was reported, treatment was stopped, and the dialyzer was replaced.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: d10, h3, h6 and h10.The device was received for evaluation.Visual inspection with the naked eye did not identify any abnormalities that could have contributed to the reported condition.A leakage test of dialysate side was performed and a crack in the welding zone was found.The reported condition was verified.Review of the welding parameters of the product were within specification.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: the actual device was not available; however, a video and four photographs of the sample were provided for evaluation.Visual inspection of the provided video showed an external fluid leakage at the connection between the header and the housing.The leakage was not visible on the provided photos.The cause of the reported issue 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 170H
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9459250
• Report Number: 9611369-2019-00191
• Device Sequence Number: 14222560
• Product Code: KDI
• UDI-Device Identifier: 07332414037932
• UDI-Public: (01)07332414037932
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K043342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2020

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: 06/30/2022
• Device Catalogue Number: 103579
• Device Lot Number: 9-4608-H-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/19/2019; 01/22/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/08/2020; 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1