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 Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Vomiting (2144); Loss of consciousness (2418)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between the use of the optiflux 160nre dialyzer and the event of a dialyzer reaction, characterized by vomiting, hypotension, loss of consciousness and pruritis.It is well documented that patients on hd therapy may experience reactions involving non-biocompatibility due to the composition of dialyzer membranes of various types of dialyzers.In the optiflux instructions for use, it cautions users of the known risk of adverse reactions such as ¿itching, flushing, hives, swelling, fever, leukopenia, hypotension, hypertension, shortness of breath with wheezing, arrhythmias, and/or respiratory arrest¿.Based on the available information, there is no allegation or objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction, caused or contributed to the patient¿s serious adverse events.

Event Description

A purchasing manager reported to fresenius customer service that a patient on hemodialysis (hd) therapy utilizing an optiflux 160nre dialyzer experienced a dialyzer reaction.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s).Upon follow up with an hd registered nurse (hdrn), it was reported this patient experienced vomiting, hypotension, loss of consciousness and pruritis during an hd treatment on (b)(6) 2021.The patient was not hospitalized for this event and was given prednisone and diphenhydramine (unknown route, dose, frequent and duration).The patient is stable and continuing their regular hd therapy.The exact cause of the patient¿s allergic reaction and associated symptoms were unknown; however, it was confirmed this event was not related to a deficiency or malfunction of any fresenius device(s) or product(s).The dialyzer used for the event was not available to be returned for manufacturer evaluation.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not 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 one non-conformance (nc) during the production of this lot which was unrelated to the reported complaint event.There was no indication of product nonacceptance, deviation, nc, 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 without physical examination of the actual device.Therefore, the complaint is not confirmed.

Event Description

A purchasing manager reported to fresenius customer service that a patient on hemodialysis (hd) therapy utilizing an optiflux 160nre dialyzer experienced a dialyzer reaction.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s).Upon follow up with an hd registered nurse (hdrn), it was reported this patient experienced vomiting, hypotension, loss of consciousness and pruritis during an hd treatment on (b)(6) 2021.The patient was not hospitalized for this event and was given prednisone and diphenhydramine (unknown route, dose, frequent and duration).The patient is stable and continuing their regular hd therapy.The exact cause of the patient¿s allergic reaction and associated symptoms were unknown; however, it was confirmed this event was not related to a deficiency or malfunction of any fresenius device(s) or product(s).The dialyzer used for the event was not available to be returned for manufacturer evaluation.

• 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: 11989181
• MDR Text Key: 255936712
• Report Number: 1713747-2021-00181
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 21AU06010
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 70