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 Headache (1880); Pain (1994); Diaphoresis (2452)

Event Date 09/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that approximately six minutes into the treatment with a polyflux 14l, the patient experienced headache, lumbago, palpitation, and sweating.The patient was administered 300ml intravenous infusion of 0.9% sodium chloride injection, oxygen inhalation and 10 mg dexamethasone (intravenous) for the events.The set was replaced, and treatment was restarted ten minutes later with no further patient symptoms.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
• MDR Report Key: 12578648
• MDR Text Key: 281077872
• Report Number: 9611369-2021-00268
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414086633
• UDI-Public: (01)07332414086633
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 109651
• Device Lot Number: 0-5168-H-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Required Intervention