MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX; DIALYZER, CAPILLARY, HOLLOW FIBER

Catalog Number	102058
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Erythema (1840); Heartburn/Indigestion (1883); Hemolysis (1886); Hiccups (1899); High Blood Pressure/ Hypertension (1908); Malaise (2359)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter last name: (b)(6).E1: initial reporter facility name: (b)(6).E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported approximately two hours after the start of a hemodialysis therapy, with a polyflux 17 l dialyzer, the patient experienced symptoms including hypertension, stomachache, general unwellness, skin redness, dark urine, hiccups, and heartburn.The patient required medical intervention in the hospital for hydration, red blood cell transfusion, and more effective dialysis.The patient was hospitalized for approximately three days and then discharged.Dialysis therapy remains ongoing.The patient's hemoglobin level is still low and skin color returned to normal.No additional information received.
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The visual inspection and measurements of the inner diameters were within product specification.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.

• Brand Name: POLYFLUX
• Common Device Name: DIALYZER, CAPILLARY, HOLLOW FIBER
• 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: 16778120
• Report Number: 9611369-2023-00052
• Device Sequence Number: 6708863
• Product Code: FJI
• UDI-Device Identifier: 07332414036416
• UDI-Public: (01)07332414036416
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K043342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 102058
• Device Lot Number: 2-4327-H-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 14G SAFETY NEEDLES.; AK 98, 230V, MACHINE.; NIPRON SAFETOUCH DIALYSIS CATHETER.; NOVALINE TUBING.; WRO 300 H, REVERSE OSMOSIS MACHINE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 87 KG