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 Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Reaction (2414)

Event Date 06/19/2020

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 180nre dialyzer and the event of a dialyzer reaction, characterized by transient hypotension and bradycardia.It is well documented that patients on hemodialysis may experience reactions involving non-biocompatibility due to the composition of dialyzer membranes of various types of dialyzers.The fresenius optiflux f180 nre dialyzer instructions for use 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

It was reported that a hemodialysis (hd) patient had a drop in blood pressure and heart rate, and it was claimed that it was due to a dialyzer reaction.Upon follow-up with the user facility administrator (admin), it was reported that the patient was undergoing hemodialysis (hd) in the intensive care unit (icu).The admin stated that the patient was in the icu for reasons unrelated to hd therapy, however, the reasons were not provided.The admin stated that the patient did not develop and additional symptoms, injury, adverse event, or require medical intervention as a result of the reported event.The patient was able to complete treatment on the same machine with the same supplies.The admin stated the patient¿s doctor wants to try a dialyzer that is sterilized differently than the dialyzer that is currently being used.Additional patient and treatment details were requested but not provided.The sample is not available to be returned to the manufacturer for evaluation because it was discarded.

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.Six lots were found to have been delivered in this time period.A production records review was performed on the reported lots.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on five of the lots which were unrelated to the complaint event.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 lots 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.

• 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
• MDR Report Key: 10290083
• MDR Text Key: 199308111
• Report Number: 1713747-2020-00293
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

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
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 07/21/2020
• Supplement Dates FDA Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention