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 Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity. Clinical investigation: a temporal relationship exists between hd therapy utilizing the fresenius optiflux 160nre dialyzer, and the serious adverse events of pain and chronic rash (exacerbated by hd therapy). The definitive etiology of the events is unknown; therefore, causality cannot be firmly established. However, follow-up with the cm revealed the patient had a favorable response to an alternative dialyzer (nipro cellentia 17h), with a substitute mode of sterilization. The cm reported the patient underwent hd without a return or worsening of the patient¿s rash or pain. Limited information precluded a more comprehensive investigation. Based on the totality of the information available, the fresenius optiflux 160nre dialyzer cannot be excluded from having a possible causal and/or contributory role in the patient¿s serious adverse events. While uncommon, hypersensitivity reactions are known to occur with the use of optiflux dialyzers and/or other elements in the extracorporeal circuit. Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model.

Event Description

It was reported to fresenius that a patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) was experiencing a chronic rash, which worsened while undergoing hd therapy utilizing an optiflux 160nre dialyzer (specifics not provided). Follow-up with the outpatient clinical manager (cm) revealed a substitute dialyzer (nipro cellentia 17h) was utilized on (b)(6) 2021 with favorable results. The patient reportedly completed treatment without any complaints of pain or rash. Subsequent attempts to obtain additional information (e. G. , patient demographics, treatment records, medical records, current disposition) have thus far proven unsuccessful.

• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 12164910
• MDR Text Key: 261467584
• Report Number: 1713747-2021-00216
• 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: health professional,user faci

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• 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
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 07/22/2021
• 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: 07/14/2021 Patient Sequence Number: 1