MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 170H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 112466

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

Patient Problems Abdominal Pain (1685); Low Blood Pressure/ Hypotension (1914); Sweating (2444)

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 a patient being treated with a polyflux 170h dialyzer, experienced abdominal pain (described as similar to premenstrual syndrome abdominal cramp), sweating and a drop in blood pressure.The patient was treated with an unspecified antihistamine, but the symptoms persisted.It was reported that after blood return was performed, the patient was switched to a different dialyzer brand, and the symptoms resolved.There was no patient injury or medical intervention associated with this event.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 170H
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10277084
• MDR Text Key: 199073555
• Report Number: 9611369-2020-00088
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414102760
• UDI-Public: (01)07332414102760
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• 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: 08/06/2020

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 Expiration Date: 11/30/2020
• Device Catalogue Number: 112466
• Device Lot Number: 7-4505-H-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 07/28/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention