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 Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Urticaria (2278)

Event Date 05/08/2023

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between hd treatment utilizing the fresenius optiflux180nre dialyzer and the patient¿s symptoms of itch and hives consistent with an adverse event of allergic/hypersensitivity reaction to the dialyzer.The patient was treated per standard of care and did not experience any other adverse effects or require any additional medical intervention.The actual sample of the optiflux 180nre dialyzer used during the event has reportedly been discarded and dialyzer will not be returned to the manufacturer for analysis.However, 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 180 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 180 nre dialyzer.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported by a facility administrator that a patient on hemodialysis (hd) experienced an allergic reaction to the dialyzer.In additional follow-up with the facility administrator and a hemodialysis nurse familiar with the event the following information was obtained: it was reported that the dialysis facility typically uses the optiflux nr 180 dialyzers, noting that the label on the optiflux nre 180 dialyzer was new (different product).On (b)(6) 2023, this patient received hemodialysis via the optiflux nre 180 dialyzer.Approximately 1.5 hours into the hemodialysis treatment, the patient developed symptoms of itch and hives.It was stated that the patient was treated with benadryl 25 mg by mouth and 12.5 mg intravenously (iv) according to patient pre-existing standing orders for itch.The patient¿s treatment was ended (time not provided).The nurse confirmed the patient experienced minimal blood loss (approx.250 cc; contained in dialyzer) as the patient¿s blood was not rinsed back (returned blood in the extracorporeal circuit).The nurse indicated the blood loss did not cause any harm to the patient.Additionally, it was stated the patient¿s symptoms resolved without need for further medical intervention.The patient resumed the next scheduled hemodialysis treatment on utilizing the optiflux 180 nr dialyzer (from facility stock) without any further issues.The dialyzer in use at the time of the event was discarded; lot # could not be provided.The nurse confirmed the facility has not experienced any other patients having issue with the optiflux 180 nre dialyzers.

Event Description

It was reported by a facility administrator that a patient on hemodialysis (hd) experienced an allergic reaction to the dialyzer.In additional follow-up with the facility administrator and a hemodialysis nurse familiar with the event the following information was obtained: it was reported that the dialysis facility typically uses the optiflux nr 180 dialyzers, noting that the label on the optiflux nre 180 dialyzer was new (different product).On (b)(6) 2023, this patient received hemodialysis via the optiflux nre 180 dialyzer.Approximately 1.5 hours into the hemodialysis treatment, the patient developed symptoms of itch and hives.It was stated that the patient was treated with benadryl 25 mg by mouth and 12.5 mg intravenously (iv) according to patient pre-existing standing orders for itch.The patient¿s treatment was ended (time not provided).The nurse confirmed the patient experienced minimal blood loss (approx.250 cc; contained in dialyzer) as the patient¿s blood was not rinsed back (returned blood in the extracorporeal circuit).The nurse indicated the blood loss did not cause any harm to the patient.Additionally, it was stated the patient¿s symptoms resolved without need for further medical intervention.The patient resumed the next scheduled hemodialysis treatment on utilizing the optiflux 180 nr dialyzer (from facility stock) without any further issues.The dialyzer in use at the time of the event was discarded; lot# could not be provided.The nurse confirmed the facility has not experienced any other patients having issue with the optiflux 180 nre dialyzers.

Manufacturer Narrative

Plant investigation:the complaint could not be confirmed, as a definitive conclusion cannot be reached based on the limited information provided.As no lot number was provided by the complainant, a system delivery search was performed to identify all lot numbers with the reported catalog number shipped to the complainant in the three months prior to the occurrence date.There were eight lot numbers delivered to the complainant in this time period, and a lot history review was performed on each identified lot.The production record review showed there were one to multiple approved temporary dns in the production of multiple lots and one non-conformance.They are unrelated to the reported complaint event.There was no indication of product non-acceptance or deviation in the manufacturing process related to the complaint event.A recent dialyzer label change included using a different color for each dialyzer size/type (for ease of differentiating between them) as well as adding the letter ¿e¿ to the end of the dialyzer size, to more easily show if the dialyzer is ebeam or steam sterilized.This change affected the labels only, and no change was made to the device itself.A notification letter was sent to all clinics beforehand to make them aware of the label update.Both models ("old" and "new") referred to by the reporter are the same model/dialyzer type.Continuous improvement is of the utmost importance to fresenius medical care as we strive to provide dialysis products of the highest quality to our patients.Reports of leaking product are investigated both individually as complaints, as well as via the nc/capa program, in order to assess and improve our products and processes.Capas for vision systems and blood leak reduction are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.

• 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: 17003875
• MDR Text Key: 315948383
• Report Number: 0001713747-2023-00346
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 06/16/2023
• 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): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male