MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION DIALYZERS / ULTRAFILTERS (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 Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Diaphoresis (2452); Pallor (2468)

Event Date 01/18/2023

Event Type  Injury  

Event Description

It was reported that shortly after starting of treatment with a polyflux 140h, the patient became pale, profuse sweating and accompanied by "precordial discomfort".The blood pressure (bp) was 84/57mmhg.An allergic reaction to the dialyzer or tube was suspected.Immediately the ultrafiltration was stopped, oxygen inhalation was provided, ecg monitoring and "rapid volume expansion" were initiated.In addition dexamethasone 5mg iv, after intravenous injection of calcium gluconate was infused.Post iv treatment, the blood pressure rose to 120/57mmhg.No additional information is available.

Manufacturer Narrative

Initial reporter address - (b)(6).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: DIALYZERS / ULTRAFILTERS (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: 16709798
• MDR Text Key: 312984933
• Report Number: 9611369-2023-00044
• 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
• Report Date: 04/10/2023

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: 109651
• Device Lot Number: 2-5130-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/10/2023
• Date Device Manufactured: 04/07/2023
• 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: NI.
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male