MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 210H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 955610

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Thrombocytopenia (4431)

Event Date 06/17/2021

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 after treatment with a polyflux 210h, the patient's platelet count decreased from 25.3 to 1.8 (units not provided) and they experienced chest pain , breathing difficulty and a decrease in blood pressure during the event.The event occurred on the 3rd time of using a polyflux dialyzer on the patient.No additional information is available.

Manufacturer Narrative

Additional information added to h6 and h10 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 210H
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12224936
• MDR Text Key: 263393804
• Report Number: 9611369-2021-00175
• Device Sequence Number: 1
• Product Code: KDI
• 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: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 955610
• Device Lot Number: 0-5578-H-08
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JMS GCX-01; NIPRO FB-90U; JMS GCX-01; NIPRO FB-90U
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Weight: 31