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 Problem Itching Sensation (1943)

Event Date 08/13/2019

Event Type  Injury  

Manufacturer Narrative

Clinical review: a clinical investigation was performed.A temporal relationship exists between hd therapy utilizing the optiflux 160 nre dialyzer and the serious adverse events of itching and hyperglycemia.The cause of the itching was attributed to a hyperglycemic reaction.Per the pdrn, the patient has resumed the use of the optiflux 160nre dialyzer without issue.Based on the information available, the optiflux 160nre dialyzer can be disassociated from the events, as there is no allegation or objective evidence indicating an optiflux 160 nre dialyzer product deficiency or malfunction caused or contributed to the serious adverse events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility clinic nurse reported that a hemodialysis patient experienced a hypersensitive reaction (itching) while using the optiflux f160 nr dialyzer.Upon follow up, the nurse stated that the itching occurred during treatment.The patient was hospitalized.The patient was switched to cellulose dialyzer for a short period of time and returned to the optiflux dialyzer.The patient¿s physician stated that the reaction was not related to the optiflux dialyzer membrane.The reaction was attributed to the patient¿s blood sugar levels being high.The patient is continuing treatment using the optiflux dialyzer without any other complications or repeat of the event.

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, a search was performed to obtain all lot numbers, performed to obtain all lot numbers with the reported catalog number delivered to the customer in the three months prior to the complaint occurrence date.There were no lots delivered in that time period.The search was then extended to find the last delivered lot with the reported catalog number.A review of the production record was performed.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 reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed 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 160NRE DIALYZER FINISHED ASSY.
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• MDR Report Key: 8949392
• MDR Text Key: 158634599
• Report Number: 1713747-2019-00282
• 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,Followup
• Report Date: 10/08/2019

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: 08/13/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 09/10/2019; 10/07/2019
• Supplement Dates FDA Received: 09/11/2019; 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 57