MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 210H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 112467

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6). Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a blood leakage on a polyflux 210h dialyzer. The issue was found during treatment. The leak was noted to be due to a crack and a loose header. There was patient involvement, however there was no injury or medical intervention associated with the reported event. No additional information is available.

Manufacturer Narrative

The device was returned for evaluation. A visual inspection was performed and it was noted that there was a cracked welding seam. A leak test was also performed and the cracked welding zone was found. The reported condition was verified. The cause of the reported condition was a pur residual on the welding zone which was a manufacturing issue. A nonconformance has been opened to address this issue. 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 210H
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 8160803
• Report Number: 9611369-2018-00141
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414102777
• UDI-Public: (01)07332414102777
• Combination Product (y/n): N
• PMA/PMN Number: K043342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 112467
• Device Lot Number: 8-6308-H-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No