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 Abdominal Pain (1685); Chest Pain (1776); Diarrhea (1811); Hemorrhage/Bleeding (1888); Nausea (1970); Vomiting (2144); Hot Flashes/Flushes (2153)

Event Date 08/28/2023

Event Type  Injury  

Event Description

Fresenius received a voluntary medwatch (mw5145376) report stating that a hemodialysis (hd) patient utilizing an optiflux f180nre dialyzer began complaining of nausea, vomiting, diarrhea, abdominal pain, chest tightness, and flushing within minutes of hd treatment initiation.Additional information was obtained through follow-up with the clinical nurse manager.The patient arrived for a regularly scheduled four-hour hd treatment.The patient¿s treatment was initiated at 1200 hours.Within the first minute of treatment start, the patient complained of nausea, vomiting, diarrhea, abdominal pain, chest tightness, and flushing.The treatment was discontinued, and time noted at 1200 hours.The patient¿s blood was not rinsed back, and the estimated blood loss was 100ml.The patient was administered ondansetron 4mg intravenous push (ivp) and diphenhydramine 50mg ivp.The patient recovered on site and was discharged home in stable condition.The patient resumed treatment on a subsequent date with an optiflux f180nr dialyzer without incident.The f180nre dialyzer was added as an allergy to the patient¿s medical history.This event was classified as a dialyzer reaction.The patient does not require any additional pre-treatment medication with the f180nr dialyzer.The dialyzer is to be flushed with saline per protocol.No sample was expected to be returned for evaluation.

Manufacturer Narrative

Clinical investigation: based on the available information, there is a temporal and likely causal relationship between the fresenius opitflux f180nre dialyzer and the patient¿s reaction (characterized by nausea, vomiting, diarrhea, abdominal pain, chest tightness, and flushing).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.Type a reactions usually begin in the first few minutes of dialysis and are associated with symptoms such as itching, burning sensation at the access site, urticaria, flushing, cough, sneezing, wheezing, abdominal cramps, diarrhea, headache, back and chest pain, nausea, vomiting, fever, and chills.Although the patient experienced an adverse reaction during treatment, there is no allegation of a product malfunction or deficiency related to this event.Plant investigation: no sample was 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 with the information provided.Therefore, the complaint was 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: 17909050
• MDR Text Key: 325338479
• Report Number: 0001713747-2023-00692
• 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
• Report Date: 10/10/2023

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 Catalogue Number: 0500318E
• Device Lot Number: 23JU07018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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): Required Intervention; Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 107 KG