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

Catalog Number 0500316E

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between hd treatment utilizing the fresenius optiflux160nre dialyzer and the patient¿s symptoms of itch and hives consistent with an adverse event of allergic/hypersensitivity reaction to the dialyzer.The actual sample of the optiflux 160nre dialyzer used during the event is not available for further product analysis.However, currently there is no allegation nor any objective evidence that the optiflux 160nre dialyzer malfunctioned or product deficiency.Medical literature review demonstrates that it is well-documented that patients on hemodialysis may experience hypersensitivity and allergic reactions to various types of dialyzers due to differences in dialyzer membranes and/or sterilant.Moreover, the fresenius optiflux 160 nre dialyzer manufacturer instructions for use document that side effects of hypersensitivity reactions may occur with use of the product.Therefore, the product cannot be excluded as a causal factor in this event given the known potential side effect of an allergic reaction while using the optiflux 160 nre dialyzer.

Event Description

On 19/dec/2023, post market surveillance at fresenius medical care was notified that on 27/nov/2023 a medical device report (mdr) was filed with the fda for an adverse event of dialyzer reaction and itching involving a hemodialysis patient.Contained in the report was that on (b)(6) 2023, the patient began the first outpatient hemodialysis treatment utilizing the fresenius optiflux 160 nre dialyzer (lot number unknown).Pre-treatment vital signs recorded as blood pressure 142/62, pulse 64, respiration rate 16, and temperature 97.Approximately 3 hours into the hemodialysis treatment, this patient developed symptoms of itching with hives on the patient¿s upper chest/neck.The patient utilized the fresenius optiflux 160 nre dialyzer (lot number unknown) for the hemodialysis treatment.The patient was initially treated with 50mg of benadryl intravenously (iv), administration of a normal saline (ns) bolus (amount not known) and administration of oxygen (details unknown).The patient¿s hemodialysis treatment was ended.The patient continued to experience formation of hives spreading to the patient¿s back approx.5-10 minutes after and therefore the patient was sent to the hospital via emergency medical services (ems) for further evaluation.The fresenius optiflux 160 nre dialyzer (lot number unknown) was not available for further product investigation.No further information about the event is available despite several follow-up attempts to reach the initial reporter.

Event Description

On 19/dec/2023, post market surveillance at fresenius medical care was notified that on 27/nov/2023, a medical device report (mdr) was filed with the fda for an adverse event of dialyzer reaction and itching involving a hemodialysis patient.Contained in the report was that on (b)(6) 2023, the patient began the first outpatient hemodialysis treatment utilizing the fresenius optiflux 160 nre dialyzer (lot number unknown).Pre-treatment vital signs recorded as blood pressure 142/62, pulse 64, respiration rate 16, and temperature 97.Approximately 3 hours into the hemodialysis treatment, this patient developed symptoms of itching with hives on the patient¿s upper chest/neck.The patient utilized the fresenius optiflux 160 nre dialyzer (lot number unknown) for the hemodialysis treatment.The patient was initially treated with 50mg of benadryl intravenously (iv), administration of a normal saline (ns) bolus (amount not known) and administration of oxygen (details unknown).The patient¿s hemodialysis treatment was ended.The patient continued to experience formation of hives spreading to the patient¿s back approx.5-10 minutes after and therefore the patient was sent to the hospital via emergency medical services (ems) for further evaluation.The fresenius optiflux 160 nre dialyzer (lot number unknown) was not available for further product investigation.No further information about the event is available despite several follow-up attempts to reach the initial reporter.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As no lot number was provided for this complaint, an search was performed to obtain all lot numbers with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.However an identifier was not provided, therefore a lot history could not be performed.The lot trend could not be evaluated as a specific lot number was not provided.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 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
• 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: 18425883
• MDR Text Key: 331866154
• Report Number: 0001713747-2024-00002
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

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: 0500316E
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2024
• 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
• Treatment: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Patient Outcome(s): Required Intervention