MAUDE Adverse Event Report: GAMBRO DIALYSATOREN GMBH POLYFLUX 210H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number POLYFLUX 210 H

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

Patient Problem Hemolysis (1886)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A home patient in (b)(6) was undergoing a dialysis treatment using a polyflux 210 h dialyzer.The patient reported that they felt unwell towards the end of treatment.The extracorporeal blood was reported to be light red in color.The patient was admitted to the hospital where hemolysis was diagnosed.No additional information is available.

• Brand Name: POLYFLUX 210H
• 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 ; 2249487578
• MDR Report Key: 6348329
• MDR Text Key: 67925093
• Report Number: 9611369-2017-00023
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Model Number: POLYFLUX 210 H
• Device Catalogue Number: 103580
• Device Lot Number: 6-9041-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2016
• 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): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 60