MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500316E

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

Patient Problem Itching Sensation (1943)

Event Date 09/01/2021

Event Type  Injury  

Event Description

A patient contacted the fresenius compliance hotline and complained of itchy skin when using a fresenius dialyzer. Additional follow-up was conducted with a hemodialysis (hd) nurse familiar with the patient. The nurse stated the patient did not experience any serious adverse effects from use of the optiflux 160nre dialyzer. It was reported that the patient has pre-existing allergies and sensitive skin which is aggravated by anxiety. Per the nurse, the patient takes over the counter zyrtec at home. Additionally, it was stated the patient had been having ongoing itching at the hemodialysis catheter site, allegedly caused by low quality adhesive bandages (not a fresenius product) used to protect the site. Per the nurse, in (b)(6) 2021 (exact date unknown), the patient had their hemodialysis treatment via a fresenius optiflux 160nre dialyzer for hemodialysis per physician order. It was stated the patient complained of generalized itching during dialysis with the optiflux 160nre dialyzer. The nurse indicated the event did not result in any medical intervention and was managed with the patients over the counter zyrtec. Reportedly, the patient was able to complete the treatment without any adverse effects. Subsequently, the patient was changed to a fresenius optiflux 180nr dialyzer which gets rinsed with a bag of saline before each hd treatment. No further incidents of itching was reported. Additionally, the patient was ordered a special tegaderm bandage (not a fresenius product) for their hd catheter site, according to the nurse.

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity. Clinical investigation: an association exists between hd treatment utilizing the fresenius optiflux 160nre dialyzer and the patient¿s symptoms of itching. However, there is no objective evidence that the patient¿s itching was related to a malfunction or product issue with the fresenius optiflux 160nre dialyzer. Dialyzer reactions are a well-documented potential complication during hemodialysis. The patient had a reported medical history that is significant for pre-existing allergies, sensitive skin (with itch at the hemodialysis site) and anxiety (which worsens itch). While the patient complained of itching, the event was managed with the patients over the counter zyrtec and the patient completed the hemodialysis treatment without any further event(s). The patient has since resumed hemodialysis using another fresenius dialyzer without further reported issue.

• Brand Name: OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12724245
• MDR Text Key: 282343164
• Report Number: 1713747-2021-00407
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 0500316E
• Device Catalogue Number: 0500316E
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 12/30/2021
• 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: 10/29/2021 Patient Sequence Number: 1