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

Catalog Number 109651

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

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Wheezing (4463)

Event Date 03/09/2024

Event Type  Injury  

Event Description

It was reported that ¿18 minutes¿ after starting dialysis treatment while using a polyflux dialyzer, the patient experienced ¿shortness of breath, dyspnea, dry and wet rale and wheezing in both lungs¿.The patient¿s heart rate was reported to be 130 beats per minute and the blood pressure was recorded as 167/84mmhg further reported as ¿increased significantly¿.Dialysis treatment was discontinued.As treatment for the symptoms, the patient was given intravenous infusions of dexamethasone 10 mg, 20ml of 10% calcium gluconate injection in 100 ml of normal saline, and amiodarone injection 150mg in 20 ml of 5% glucose.The patient was also given unspecified ¿other symptomatic treatment, such as anti-allergy, anti-arrhythmia¿ and oxygen inhalation.The patient¿s shortness of breath and dyspnea were reported to be ¿slightly relieved¿ approximately 30 minutes after treatment was given.The patient was transferred to the icu for bedside hemofiltration treatment and was reported to be ¿stable¿.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information has been added to h6 and h10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 19092302
• MDR Text Key: 339982365
• Report Number: 9611369-2024-00070
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414086633
• UDI-Public: (01)07332414086633
• 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,Followup
• Report Date: 04/25/2024

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: 109651
• Device Lot Number: 3-5138-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 04/25/2024
• 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
• Patient Outcome(s): Hospitalization; Required Intervention