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

Catalog Number	102058
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 two polyflux 17l, two internal blood leak were observed.The first event occurred 10 minutes after starting treatment.It was reported the dialyzer membranes/fibers were found broken ¿internally¿.Treatment was discontinued.Therapy was restarted with a new dialyzer and 10 minutes after starting treatment the membranes/fibers were found broken.Treatment was discontinued.Therapy was restarted with a new dialyzer and no issues were noted.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection by the naked eye did not identify any abnormalities that could have contributed to the reported condition.Leakage tests of blood side and the dialysate side were performed and the results did not identify any leakages, as no leaks were found.The reported condition was not verified.The cause of the condition 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
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 8464714
• Report Number: 9611369-2019-00041
• Device Sequence Number: 240192
• Product Code: KDI
• UDI-Device Identifier: 07332414037932
• UDI-Public: (01)07332414037932
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/25/2019

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: 06/30/2021
• Device Catalogue Number: 102058
• Device Lot Number: 8-4331-H-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1