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); Itching Sensation (1943); Swelling/ Edema (4577)

Event Date 12/16/2022

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 shortness of breath, itching, and face swelling).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, although mild, to another manufacturer¿s dialyzer.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

It was reported via voluntary medwatch (report # (b)(4)) that a hemodialysis (hd) patient experienced an allergic reaction to the fresenius optiflux 180nre dialyzer.This patient had their first 2008t machine hemodialysis (hd) treatment utilizing the fresenius optiflux 180nre dialyzer on (b)(6) 2022 with no issues.On (b)(6) 2022, the patient arrived for a regularly scheduled hd treatment.The patient¿s pre-treatment vitals were as follows: blood pressure (bp) 182/95, pulse 97, respiration 18, temperature 97.2°.The treatment was scheduled for 3 hours and 45 minutes.The patient utilized a 2008t machine, combiset bloodlines, the optiflux 180nre dialyzer, normal saline, granuflo 2.0k 2.5ca 1.0mg, and naturalyte bicarb.At approximately 0743 hours, treatment was initiated and within approximately fifteen minutes, the patient complained of shortness of breath, itching, and face swelling.Treatment was terminated.The blood from the arterial blood line was returned.The registered nurse (rn) administered benadryl 50mg intravenous push (ivp) and solu-medrol 125mg ivp.The patient was also administered 2l of oxygen (o2) via nasal canula (nc).Emergency medical services (ems) were called.The patient was transported to the emergency department (ed).The patient¿s vitals at time of transport were bp 176/95, p96.The patient dialyzed at the ed as inpatient and was discharged home on the same date.The patient returned to the clinic for regularly scheduled hd treatments.On (b)(6) 2022, the patient experienced a mild reaction of itching while utilizing a nipro cellentia dialyzer.The patient is now receiving hd via nxstage hd machine without complication.The patient plans to transition to home peritoneal dialysis (pd).The optiflux dialyzer from on (b)(6) 2022 was available to be returned for manufacturer evaluation.

Event Description

It was reported via voluntary medwatch (report #(b)(4)) that a hemodialysis (hd) patient experienced an allergic reaction to the fresenius optiflux 180nre dialyzer.This patient had their first 2008t machine hemodialysis (hd) treatment utilizing the fresenius optiflux 180nre dialyzer on (b)(6) 2022 with no issues.On (b)(6) 2022, the patient arrived for a regularly scheduled hd treatment.The patient¿s pre-treatment vitals were as follows: blood pressure (bp) 182/95, pulse 97, respiration 18, temperature 97.2°.The treatment was scheduled for 3 hours and 45 minutes.The patient utilized a 2008t machine, combiset bloodlines, the optiflux 180nre dialyzer, normal saline, granuflo 2.0k 2.5ca 1.0mg, and naturalyte bicarb.At approximately 0743 hours, treatment was initiated and within approximately fifteen minutes, the patient complained of shortness of breath, itching, and face swelling.Treatment was terminated.The blood from the arterial blood line was returned.The registered nurse (rn) administered benadryl 50mg intravenous push (ivp) and solu-medrol 125mg ivp.The patient was also administered 2l of oxygen (o2) via nasal canula (nc).Emergency medical services (ems) were called.The patient was transported to the emergency department (ed).The patient¿s vitals at time of transport were bp 176/95, p96.The patient dialyzed at the ed as inpatient and was discharged home on the same date.The patient returned to the clinic for regularly scheduled hd treatments.On (b)(6) 2022, the patient experienced a mild reaction of itching while utilizing a nipro cellentia dialyzer.The patient is now receiving hd via nxstage hd machine without complication.The patient plans to transition to home peritoneal dialysis (pd).The optiflux dialyzer from (b)(6) 2022 was available to be returned for manufacturer evaluation.

Manufacturer Narrative

Plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no sample has been received.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 one approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.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.

• 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: 16153370
• MDR Text Key: 307263579
• Report Number: 0001713747-2023-00026
• 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: 02/01/2023

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: 22AU04012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; GRANUFLO 2.0K 2.5CA 1.0MG; GRANUFLO 2.0K 2.5CA 1.0MG; NATURALYTE BICARB; NATURALYTE BICARB; NORMAL SALINE; NORMAL SALINE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: Black Or African American