MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number OPTIFLUX DIALYZER

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

Patient Problems Headache (1880); Malaise (2359)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.

Event Description

A clinical support specialist reported that a hemodialysis (hd) patient experienced a headache and felt ¿very tired¿ (malaise) following completion of hd therapy [date(s) not provided]. The patient reportedly felt these symptoms after dialyzing with a fresenius optiflux dialyzer. Consequently, the user facility trailed the nipro elisio dialyzer and the symptoms disappeared. The patient had previously utilized a baxter revaclear dialyzer for treatment, when they were being treated at a (b)(6) clinic. Upon follow up with the clinic manager (cm), it was reported that the patient has continued to utilize the nipro elisio dialyzer with no further complaints of headache or malaise. Multiple attempts have been made to obtain additional information from the cm, related to the reported event. At this time, no further information has been provided.

• Brand Name: OPTIFLUX DIALYZER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 9549479
• MDR Text Key: 173883190
• Report Number: 1713747-2020-00003
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: OPTIFLUX DIALYZER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 02/06/2020
• 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: Initial

Patient Treatment Data

Date Received: 01/03/2020 Patient Sequence Number: 1