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

Catalog Number 0500318E

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

Patient Problems Apnea (1720); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 08/16/2023

Event Type  Injury  

Event Description

On 12/sep/2023 , it was reported to fresenius that this patient with end stage renal disease (esrd) on hemodialysis (hd) utilizing a optiflux 180nre dialyzer for renal replacement therapy (rrt) experienced a hypersensitivity/allergic reaction during treatment.The patient arrived for their regularly scheduled treatment on (b)(6) 2023.The patient¿s pre-treatment vital signs included: blood pressure (b/p) = 182/99, heart rate (hr) = 73 bpm, respiration rate (rr) = 18, temperature = 97.2.The patient¿s hd treatment was started at 11:05 am, however at 11:13 am, the patient became unresponsive (loss of consciousness) and became hypotensive, and experienced body ¿jerking¿ (muscle spasm) and was apneic.The treatment was terminated, and the patient¿s blood was reinfused utilizing normal saline (volume not provided).The patient¿s post-treatment vitals were: b/p = 150/76, hr = 60 bpm, rr = 18, temperature = 97.0.Although the timeline was not provided, it appears the patient regained consciousness prior to the arrival of emergency medical services and was transported to the hospital.The patient reportedly returned to the outpatient dialysis clinic (date not provided) and was treated utilizing a nipro cellentia 17h dialyzer without incident.Additional information was requested however a response was not received.No samples were returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing the optiflux 180nre dialyzer, and the serious adverse events of a hypersensitivity/allergic reaction, characterized by apnea, hypotension, and loss of consciousness, which required the early termination of treatment and transport to the hospital.The serious adverse events occurred during hd therapy and were remediated by the utilization of an alternative dialyzer (nipro cellentia 17h - alternative sterilant).During hd therapy, blood comes into direct contact with a variety of materials and sterilization methods.Therefore, it is reasonable to conclude some patients may incur a hypersensitivity/allergic reaction while using these products.Additionally, hypersensitivity reactions have been known to occur days, months, or even years after use with the same dialyzer model.Based on the information available, the optiflux 180nre dialyzer cannot be disassociated from the serious adverse events.While no manufacturing defect(s) was reported, the serious adverse events did occur during hd therapy while utilizing the optiflux 180nre dialyzer.Furthermore, given the patient¿s symptoms were indicative of a severe hypersensitivity/allergic reaction, the favorable response to the alternative dialyzer, and no sample available for manufacturer evaluation, the optiflux 180nre dialyzer cannot be excluded from having a possible causal or contributory role in the serious adverse events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Manufacturer Narrative

Plant investigation: 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 with the available information.Therefore, the complaint is not confirmed.

Event Description

On 12/sep/2023 it was reported to fresenius that this patient with end stage renal disease (esrd) on hemodialysis (hd) utilizing a optiflux 180nre dialyzer for renal replacement therapy (rrt) experienced a hypersensitivity/allergic reaction during treatment.The patient arrived for their regularly scheduled treatment on (b)(6) 2023.The patient¿s pre-treatment vital signs included: blood pressure (b/p) = 182/99, heart rate (hr) = 73 bpm, respiration rate (rr) = 18, temperature = 97.2.The patient¿s hd treatment was started at 11:05 am, however at 11:13 am the patient became unresponsive (loss of consciousness) and became hypotensive, and experienced body ¿jerking¿ (muscle spasm) and was apneic.The treatment was terminated, and the patient¿s blood was reinfused utilizing normal saline (volume not provided).The patient¿s post-treatment vitals were: b/p = 150/76, hr = 60 bpm, rr = 18, temperature = 97.0.Although the timeline was not provided, it appears the patient regained consciousness prior to the arrival of emergency medical services and was transported to the hospital.The patient reportedly returned to the outpatient dialysis clinic (date not provided) and was treated utilizing a nipro cellentia 17h dialyzer without incident.Additional information was requested however a response was not received.No samples were returned to the manufacturer for physical evaluation.

• 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: 17802504
• MDR Text Key: 324114242
• Report Number: 0001713747-2023-00643
• 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: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

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 Expiration Date: 06/03/2023
• Device Catalogue Number: 0500318E
• Device Lot Number: 23HU03001
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/03/2023
• 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