MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

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

Patient Problems Dyspnea (1816); Swelling (2091); Reaction (2414)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   clinical investigation: based on the available information, there is a temporal and a likely causal relationship between the fresenius optiflux 180nre dialyzer and the patient¿s reaction (characterized by tongue swelling, shortness of breath and difficulty talking during the hd treatment). Although rare, hypersensitivity or anaphylactoid reactions to optiflux dialyzers are a known risk during hemodialysis. There is no evidence of an optiflux 180nre dialyzer product deficiency or malfunction. Additionally, although the patient experienced an adverse reaction during treatment, there is no allegation of a product malfunction or deficiency related to this event.

Event Description

A user facility clinical manager reported a hemodialysis (hd) patient attended regularly scheduled dialysis treatment. Pre vs 118/78, pulse 106, temp 99. 1. At approximately 10:34 dialysis initiated via a left upper arm avf. Within approximately 20 minutes, the patient stated that the tongue was swelling. The patient also had shortness of breath and difficulty speaking. Oxygen was provided, 911 called, and dialysis was terminated. Blood pressure 103/64, pulse 104. The patient was transported to the emergency room and later released. The patient recovered. Upon follow up, the clinical manager stated the patient did not experience any reaction until the treatment on (b)(6) 2019 with use of the optiflux 180nre dialyzer (the same dialyzer used for all previous treatments). The patient did not require hospital admission and was in the emergency room (er) for less than 24 hours prior to being discharged. The treatment received in the er is unknown. The patient continued hd treatment afterwards.

• Brand Name: OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 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: 9140423
• MDR Text Key: 167018669
• Report Number: 1713747-2019-00308
• 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
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
• Device Catalogue Number: 0500318E
• Device Lot Number: 19HU03017
• 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: 10/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2019
• 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: 10/01/2019 Patient Sequence Number: 1