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

Model Number 0500318E

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

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Tachycardia (2095)

Event Date 08/08/2022

Event Type  Injury  

Event Description

Fresenius received a voluntary medwatch from a user facility stating the patient experienced an allergic reaction to the fresenius optiflux 180nre dialyzer.This patient was at their first outpatient hemodialysis (hd) treatment and pre-treatment vitals were as follows: blood pressure (bp) 136/74, pulse 75, respiration 18, temperature 97.6°.The treatment was initiated at 1015 hours on a fresenius 2008t machine utilizing the optiflux 180nre dialyzer.At approximately 1020 hours the patient complained of shortness of breath.Per standing orders, the nurse applied 3l of o2 to the patient via nasal cannula.The patient¿s vitals were obtained and recorded as bp 151/82 and pulse 103.Emergency medical services (ems) was called.At the time of transport, the patient¿s bp was 154/68 and pulse 100.The patient was transported to the emergency room (er) via ems.The patient was admitted to the hospital.The following day the patient was initiated on hd therapy utilizing a rexeed dialyzer.The patient experienced the same symptoms upon initiation of hd treatment.It was then that the patient was diagnosed with a polysulfone allergy aggravated by ace inhibitor.Both the optiflux 180nre and rexeed dialyzers contain a polysulfone membrane.The patient¿s ace inhibitor was discontinued, and the patient was treated with intravenous (iv) benadryl and methylprednisolone.A dialyzer with a cellulose acetate membrane (manufacturer not provided) was utilized for the patient¿s third treatment.There was no allergic reaction.The patient was discharged and is now utilizing a nipro cellentia 17h dialyzer and has been stable without issues since returning to regularly scheduled hd treatment.

Manufacturer Narrative

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 shortness of breath, tachycardia, and elevated blood pressure).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.This was further supported by the patient¿s second allergic response to another manufacturer¿s dialyzer made with the same polysulfone membrane.Once the dialyzer was switched to a cellulose acetate membrane the reactions stopped.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.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

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.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.¿ a definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

Event Description

Fresenius received a voluntary medwatch from a user facility stating the patient experienced an allergic reaction to the fresenius optiflux 180nre dialyzer.This patient was at their first outpatient hemodialysis (hd) treatment and pre-treatment vitals were as follows: blood pressure (bp) 136/74, pulse 75, respiration 18, temperature 97.6°.The treatment was initiated at 1015 hours on a fresenius 2008t machine utilizing the optiflux 180nre dialyzer.At approximately 1020 hours the patient complained of shortness of breath.Per standing orders, the nurse applied 3l of o2 to the patient via nasal cannula.The patient¿s vitals were obtained and recorded as bp 151/82 and pulse 103.Emergency medical services (ems) was called.At the time of transport, the patient¿s bp was 154/68 and pulse 100.The patient was transported to the emergency room (er) via ems.The patient was admitted to the hospital.The following day the patient was initiated on hd therapy utilizing a rexeed dialyzer.The patient experienced the same symptoms upon initiation of hd treatment.It was then that the patient was diagnosed with a polysulfone allergy aggravated by ace inhibitor.Both the optiflux 180nre and rexeed dialyzers contain a polysulfone membrane.The patient¿s ace inhibitor was discontinued, and the patient was treated with intravenous (iv) benadryl and methylprednisolone.A dialyzer with a cellulose acetate membrane (manufacturer not provided) was utilized for the patient¿s third treatment.There was no allergic reaction.The patient was discharged and is now utilizing a nipro cellentia 17h dialyzer and has been stable without issues since returning to regularly scheduled hd treatment.

• 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; 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: 15348912
• MDR Text Key: 299173951
• Report Number: 0001713747-2022-00336
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

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: 0500318E
• Device Catalogue Number: 0500318E
• Device Lot Number: 22HU07017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 84 KG