MAUDE Adverse Event Report: GAMBRO DIALYSATOREN GMBH POLYFLUX 170H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 103579

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Hyperplasia (1906)

Event Date 03/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This is a report of a patient treated with hemodiafiltration since (b)(6) 2015 due to a glomerulopathy of undetermined origin.The patient has no known allergies.Prior to the treatment start the patient was in a good clinical condition.After 30 min of treatment using the polyflux 170 h dialyzer for the first time, the patient presented with symptoms of sudden dyspnea with chest pain, spasticity at auscultation and facial erythrosis.The treatment was terminated without blood restitution and immediately the patient felt better.Oxygen, atrovent and ventoline was administered to the patient.Performed ecg was reported to be normal.The treatment was not restarted and the patient returned home.No additional information is available.

• Brand Name: POLYFLUX 170H
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO DIALYSATOREN GMBH; holger-crafoord-str. 26; hechingen 72379 ; GM 72379
• Manufacturer (Section G): GAMBRO DIALYSATOREN GMBH; holger-crafoord-str. 26; hechingen ; GM
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6477054
• MDR Text Key: 72270419
• Report Number: 9611369-2017-00031
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K043342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/10/2017

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: 103579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR