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 Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Diaphoresis (2452)

Event Date 07/11/2023

Event Type  Injury  

Event Description

A registered nurse (rn) manager reported to fresenius that a 53-year-old female hemodialysis (hd) patient on in-center hd therapy experienced a dialyzer reaction on a hospital provided 2008t hd device with the optiflux 180nre dialyzer.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the rn manager, it was reported this patient was hospitalized (exact date unknown) for reasons unrelated to hemodialysis (hd) therapy or the use of any fresenius product(s) or device(s).On (b)(6)2023, during this admission, the patient underwent their first hd treatment on a hospital provided 2008t hd device.It was explained this was the patient¿s first hd treatment since transitioning to hd from peritoneal dialysis for renal replacement therapy.Approximately 10 minutes into the hd treatment, the patient experienced diaphoresis, tachycardia and hypotension without deleterious effect.The hd treatment was discontinued as the patient had an estimated blood loss of 250 ml with no report of fluid replacement.The patient was given a one-time oral benadryl (dosage unknown) per facility protocol following the reaction which promptly alleviated their symptoms.The patient also received oral protonix at the same time; however, the protonix was prescribed to address issues unrelated to hd therapy or the patient¿s dialyzer reaction.The patient was able to continue hd therapy on a hospital provided 2008t hd machine with a different dialyzer (exact model unknown) for the duration of the admission.The patient has since discharged from the hospital (exact date and patient disposition unknown).It was confirmed the patient¿s dialyzer reaction was not due to a deficiency or malfunction of any fresenius product(s) or device(s).It was assumed the patient continues hd therapy post-discharge.It was confirmed that the dialyzer was available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.During the lot history review it was noted that there were no other complaints reported against the lot.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 non-acceptance or deviation in the manufacturing process potentially related to the complaint.This includes non-conformances, rework, labeling, process controls and any other occurrence in production.The lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.Clinical investigation: a temporal relationship exists between the use of the optiflux 180nre dialyzer and the event of a dialyzer reaction, characterized by diaphoresis, tachycardia and hypotension.It is well documented that patients on any modality of hemodialysis may experience reactions involving non-biocompatibility due to the composition of dialyzer membranes of various types of dialyzers.The cause of this patient¿s adverse event can be attributed to her intrinsic physiological response to dialyzer use with no probable indication of fresenius product or device deficiency or malfunction as reported by a medical professional.Additionally, in the optiflux dialyzer model line instructions for use, it cautions users of the known risk of hypersensitivity during acute dialysis treatment.Concerning the blood loss, the amount involved can be considered innocuous as the amount lost was half of the typical blood donation with no indication of serious injury, adverse event or medical intervention.Therefore, the optiflux 180nre can be excluded as a root cause of this patient¿s adverse events.

Event Description

A registered nurse (rn) manager reported to fresenius that a 53-year-old female hemodialysis (hd) patient on in-center hd therapy experienced a dialyzer reaction on a hospital provided 2008t hd device with the optiflux 180nre dialyzer.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the rn manager, it was reported this patient was hospitalized (exact date unknown) for reasons unrelated to hemodialysis (hd) therapy or the use of any fresenius product(s) or device(s).On (b)(6) 2023, during this admission, the patient underwent their first hd treatment on a hospital provided 2008t hd device.It was explained this was the patient¿s first hd treatment since transitioning to hd from peritoneal dialysis for renal replacement therapy.Approximately 10 minutes into the hd treatment, the patient experienced diaphoresis, tachycardia and hypotension without deleterious effect.The hd treatment was discontinued as the patient had an estimated blood loss of 250 ml with no report of fluid replacement.The patient was given a one-time oral benadryl (dosage unknown) per facility protocol following the reaction which promptly alleviated their symptoms.The patient also received oral protonix at the same time; however, the protonix was prescribed to address issues unrelated to hd therapy or the patient¿s dialyzer reaction.The patient was able to continue hd therapy on a hospital provided 2008t hd machine with a different dialyzer (exact model unknown) for the duration of the admission.The patient has since discharged from the hospital (exact date and patient disposition unknown).It was confirmed the patient¿s dialyzer reaction was not due to a deficiency or malfunction of any fresenius product(s) or device(s).It was assumed the patient continues hd therapy post-discharge.

• 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: 17378310
• MDR Text Key: 320218651
• Report Number: 0001713747-2023-00481
• 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: 08/14/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0500318E
• Device Lot Number: 23DU04007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 07/24/2023
• Supplement Dates FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• 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
• Treatment: FRESENIUS 2008T MACHINE.; FRESENIUS 2008T MACHINE.
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female