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

Catalog Number 115821

Device Problem Leak/Splash (1354)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/27/2021

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that after hours (not further specified) into treatment with a polyflux 210h, an external blood leak was observed, originating from the top of the dialyzer.The treatment was terminated with blood return, however, it was reported that the patient became ¿ill¿.The blood loss was estimated to be 1.0l.No medical intervention was reported.No additional information is available.

Manufacturer Narrative

The device was not available; however, two photographs of the sample were provided for evaluation.Visual inspection of the two provided photos showed the product after treatment.An external blood leak was observed at the top of the blood nozzle of the filter.The reported condition was verified.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 210H
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEYZIEU; 7, av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12697430
• MDR Text Key: 278357261
• Report Number: 8010182-2021-00328
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414120894
• UDI-Public: (01)07332414120894
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 115821
• Device Lot Number: 1-9032-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ARTIS MACHINE; ARTIS MACHINE
• Patient Outcome(s): Other
• Patient Sex: Male