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

Catalog Number 109650

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Blurred Vision (2137); Cough (4457); Skin Inflammation/ Irritation (4545)

Event Date 03/03/2023

Event Type  Injury  

Manufacturer Narrative

The actual device was not available; however, two photographs of the sample were provided for evaluation.The visual inspection of the two provided photographs was performed.Photograph one showed the monitor with the display in chinese text.The second photograph two showed the product box with the carton label and the apac-label with the lot information.The reported condition was not verified.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.

Event Description

It was reported the patient underwent hemodialysis therapy for the first time and after three and half hours of dialysis treatment using a polyflux 17l dialyzer, the patient experienced itchy throat, itchiness over the entire body, cough, and blurred vision.Medical intervention consisted of calcium gluconate and treatment was discontinued.Ten minutes later, the patient felt drowsy, so an intravenous injection of dexamethasone 5 mg was administered.The patient felt relief after 15 minutes and was "in good condition¿.No additional information is available.

• Brand Name: POLYFLUX
• 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 - HECHINGEN BADEN DIALYZER; holger - crafoord - strasse 26; hechingen D-723 79; GM D-72379
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17125833
• MDR Text Key: 317154703
• Report Number: 9611369-2023-00099
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414086626
• UDI-Public: (01)07332414086626
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 109650
• Device Lot Number: 2-4217-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2023
• Initial Date FDA Received: 06/14/2023
• 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: FB-150F DIALYZER
• Patient Outcome(s): Required Intervention