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

Catalog Number	103530
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2020
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 after 15 minutes of starting therapy with a polyflux 140h dialyzer, reported as theranova, an external fluid leak was observed ¿from the venous end of the dialyzer¿.The extracorporeal circuit restitution was performed.Treatment was discontinued, and the dialyzer was exchanged and used without complication.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: the actual device was not available; however, picture and video of the sample were provided for evaluation.The visual inspection of the provided pictures and video showed an external leak (water droplets) on the bottom header cap during treatment.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 140H
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10900674
• Report Number: 9611369-2020-00172
• Device Sequence Number: 545592
• Product Code: KDI
• UDI-Device Identifier: 07332414037925
• UDI-Public: (01)07332414037925
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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: 10/31/2021
• Device Catalogue Number: 103530
• Device Lot Number: 85720H01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1