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 Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the complaint device was returned to the manufacturer for physical evaluation.During the gross visual examination of the sample, no defects or irregularities were visually observed on the fiber bundle or any of the molded dialyzer components.The sample was placed on the bubble point testing apparatus in order to observe the flow of water through the fiber bundle.Water was observed to flow freely throughout the center of the fiber bundle.Water flow was observed to be obstructed from entering the fibers located on the outer fiber bundle circumference at approximately 90° and 270° with the dialysate ports situated at 0°.The dialyzer subjected to a destructive disassembly for further inspection of the potting cut surface.Microscopic examination (100x) identified the fibers in the aforementioned area were plugged with pu on the cavity id end potting cut surface.There was no plugging observed in any other locations of the fiber bundle.There was no plugging observed in any location on the non-cavity id end cut surface.The inferior surface of both polyurethane potting ends were examined for voids; no voids were noted.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.The production record was reviewed and there was one approved temporary dn noted on the lot.It is unrelated to the reported complaint event.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.

Event Description

A clinic nurse at a user facility reported a dialyzer that became occluded during use.The patient¿s treatment was stopped, their blood was returned.There was no blood loss, patient injury, adverse events, or medical intervention required as a result of this event.The complaint device was returned to the manufacturer for 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; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7639397
• MDR Text Key: 112846224
• Report Number: 1713747-2018-00237
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0500316E
• Device Lot Number: 18AU06011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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