MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 14L; 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 Abdominal Pain (1685); Arrhythmia (1721); Itching Sensation (1943); Diaphoresis (2452)

Event Date 10/15/2021

Event Type  Injury  

Event Description

It was reported that 15 minutes into the treatment with a polyflux 14l dialyzer, the patient experienced itching.The patient received an intravenous injection of dexamethasone 5 mg for the event.It was reported the itching did not improve and the patient experienced sweating, palpitations and abdominal discomfort.Oxygen was administered and an electrocardiogram was performed.Treatment was discontinued 30 minutes after starting treatment.Fifteen minutes later, the dialyzer was replaced, and treatment was restarted.Fifteen minutes later, the patient reported the symptoms were relieved.No additional information is available.

Manufacturer Narrative

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 14L
• 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 ; 2242702068
• MDR Report Key: 13011339
• MDR Text Key: 285624230
• Report Number: 9611369-2021-00355
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 109651
• Device Lot Number: 0-5160-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• Date Device Manufactured: 10/22/2020
• 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): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female