MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 200NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500320E

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

Patient Problems Fever (1858); Hypersensitivity/Allergic reaction (1907); Chills (2191)

Event Date 08/19/2022

Event Type  Injury  

Event Description

It was reported that a hemodialysis (hd) patient experienced chills, aches, and a fever of 104°.During treatment utilizing the optiflux 200nre dialyzer.It was believed that the patient had a dialyzer reaction.The patient was transported to the hospital via ambulance.The patient was hospitalized for three days prior to being discharged.Attempts to obtain additional information were unsuccessful.

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 200nre dialyzer and the patient¿s reaction (characterized by chills, aches, and a fever of 104°).Although rare, hypersensitivity or anaphylactoid reactions to dialyzers are a known risk during hemodialysis.The exposure of the patient¿s blood to a foreign substance present in the extracorporeal circuit is the result of an immunoallergic response.There is no information as to whether or not the patient switched dialyzers or if the patient requires any medical intervention prior to receiving hd treatment.There is no evidence of an optiflux 200nre 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

It was reported that a hemodialysis (hd) patient experienced chills, aches, and a fever of 104°.During treatment utilizing the optiflux 200nre dialyzer.It was believed that the patient had a dialyzer reaction.The patient was transported to the hospital via ambulance.The patient was hospitalized for three days prior to being discharged.Attempts to obtain additional information were unsuccessful.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.The optiflux dialyzer instruction for use indicates the following: ¿in rare cases, thrombocytopenia or hypersensitivity reactions including anaphylactic or anaphylactoid reactions to the dialyzer, or other elements in the extracorporeal circuit, may occur during hemodialysis.Hypersensitivity reactions may cause mild to severe signs and symptoms, including itching, flushing, hives, swelling, fever, leukopenia, hypotension, hypertension, shortness of breath with wheezing, arrhythmias, and/or respiratory arrest.Patients with a history of hypersensitivity reactions or patients who have a history of being highly sensitive and allergic to a variety of substances should be carefully monitored during treatment.¿.

• Brand Name: OPTIFLUX 200NRE 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15455863
• MDR Text Key: 300243186
• Report Number: 0001713747-2022-00367
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100163
• UDI-Public: 00840861100163
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0500320E
• Device Catalogue Number: 0500320E
• Device Lot Number: 22EU04016
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 11/10/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic