MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500316E

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

Patient Problems Itching Sensation (1943); Swelling (2091); Dizziness (2194); Reaction (2414); Diaphoresis (2452); Chest Tightness/Pressure (2463)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

Clinical review: based on the available information, there is a temporal and a likely causal relationship between the fresenius optiflux 160nre dialyzer and the patient¿s reaction (characterized by dizziness, chest tightness, itching, with face and neck red, ears and tongue swollen, difficulty speaking, and sweating 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 160nre 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. .

Event Description

A voluntary medwatch report was received from a hemodialysis (hd) clinic manager reporting a patient adverse event.A hemodialysis (hd) patient arrived for a regularly scheduled treatment on (b)(6) 2020.This patient received dialysis three times per week with a three hour and thirty-minute treatment.The patient¿s pre-vital signs were as follows: blood pressure (bp)147/76, pulse 79, temperature 96.8.At approximately 0925 hours dialysis was initiated via an arteriovenous fistula (avf) (location not provided) utilizing the optiflux 160nre dialyzer which the patient had been using without incident since hd initiation.Within approximately 5-10 minutes into the treatment the patient complained of feeling dizzy, chest tightness and itching, as well as displaying a red face and neck, and swollen ears and tongue.In addition, the patient had difficulty speaking and was sweating.Vital signs were recorded at the time as bp 109/67 and pulse 121.Treatment was terminated at this time and the patient was administered oxygen via nasal cannula at 3l/min.The patient was also administered 400ml of normal saline (ns).At 0935 hours 911 was called and 25mg oral benadryl was administered.Emergency medical services (ems) arrived and in route to the emergency room (er) the patient was given an intramuscular (im) injection of 0.3mg epinephrine (epi).Once at the er, the patient received 50mg intravenous (iv) benadryl, 0.3mg im epi, 20mg iv famotidine and 25mg iv solumedrol.The patient was admitted to the intensive care unit (icu) for close monitoring with orders for iv benadryl as needed and scheduled famotidine twice a day (dose not provided).The patient recovered and was discharged from the hospital on (b)(6) 2020 and returned to hd therapy on (b)(6) 2020.The optiflux 160nre was marked as an allergy and the patient was switched to the nipro cellentia 17h dialyzer.

Manufacturer Narrative

Additional information: d10, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During visual evaluation, blood residue was noted in each header.No irregularity or defect was visually observed.Due to the blood contamination/product usage, other testing (e.G.Pyrogen testing, sodium clearance, performance, etc.) could not be performed for reasons of possible cross-contamination within other departments of the manufacturing facility.However, the dialyzer was subjected to a laboratory bubble point test where no internal or external leaks were observed.No other damage or irregularities were noted on the returned sample 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.The investigation into the complaint was able to confirm the reported event.

• Brand Name: OPTIFLUX 160NRE 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
• MDR Report Key: 10129152
• MDR Text Key: 195169065
• Report Number: 1713747-2020-00225
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 20AU01001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Device Age: MO
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 86