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

Catalog Number	103579
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during priming of a polyflux 170h dialyzer, black particles were observed inside the filter ¿on the blood side of the dialyzer¿.No particles were observed in the set.The set and filter were changed prior to starting treatment.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.During visual inspection by naked eye, the product was found to be wet and small black particulate matter was observed in the header on one side of the sample.The reported issue could be confirmed.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 170H
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 8200674
• Report Number: 9611369-2018-00154
• Device Sequence Number: 1952644
• Product Code: KDI
• UDI-Device Identifier: 07332414037932
• UDI-Public: (01)07332414037932
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

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: 103579
• Device Lot Number: 8-4741-H-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1