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); Anxiety (2328)

Event Date 05/19/2020

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 combi set bloodlines, optiflux 160nre dialyzer and the serious adverse events of dialyzer reaction, wheezing and anxiety, which required emergent discontinuation of hd therapy. The definitive etiology of the events is unknown; therefore, causality cannot be firmly established. However, given the patient¿s wheezing and anxiety during hd therapy, a possible causal or contributory role cannot be excluded. Based on the information available, the fresenius combi set bloodlines and/or optiflux 160nre dialyzer cannot be disassociated from the 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 that a hemodialysis (hd) patient experienced a suspected allergic reaction (per the nephrologist) to the fresenius combi set bloodlines. Follow-up with the patient¿s inpatient dialysis program manager (idpm) revealed the patient was hospitalized on (b)(6) 2020 for hyperkalemia, acute kidney failure (due to cancer, specifics not provided) and dyspnea. On (b)(6) 2020, the patient underwent a temporary hemodialysis (hd) catheter (not a fresenius product) placement and was started on intermittent hd while being monitored by telemetry in the intensive care unit (icu). The patient was alert and oriented, and after hd was initiated on (b)(6) 2020, the patient began wheezing and feeling an overwhelming sense of anxiety or ¿impending doom. ¿ initially it was felt the patient may be having a reaction to the fresenius combi set bloodlines, however further evaluation revealed the likely source of the allergic reaction to be caused by the sterilization methods of the optiflux 160nre dialyzer. The patient¿s treatment was discontinued; however no additional information was provided. The treatment record was requested; however, the request was declined. The combi set product information was not provided.

• 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: 10136409
• MDR Text Key: 194798800
• Report Number: 1713747-2020-00230
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• 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?

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 06/23/2020
• 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: 06/09/2020 Patient Sequence Number: 1