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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Reaction (2414)

Event Date 04/11/2017

Event Type  Injury  

Manufacturer Narrative

The clinical investigation and plant evaluation are in process.A supplemental medwatch report will be submitted upon completion of these activities.

Event Description

A facility clinic manager reported the patient had excessive itching with the use of the dialyzer.During follow up with the clinic manager (cm), this patient's first date of hemodialysis (hd) was (b)(6) 2017 using another manufacturer's dialyzer.No adverse effects were experienced during the patient's initial hd therapy and the patient was discharged home to continue receiving regularly scheduled outpatient hd treatments.During the first hd therapy performed at the user facility, the patient complained of severe itching within minutes of treatment initiation.No other symptoms were reported.The patient was administered 50 milligrams (mg) of intravenous (iv) benadryl, but within minutes the treatment was discontinued due to the severe itching.Treatment was not resumed so the patient was discharged home.The patient returned for the next scheduled hd treatment.The dialyzer was changed to the optiflux 180nr dialyzer assembly product for their next scheduled hd therapy, and the treatment was completed without issue.No patient adverse effects were experienced following the change to the dialyzer, and all subsequent treatments have been performed using this dialyzer without issue.The complaint device was available to be returned to the manufacturer for analysis.

Manufacturer Narrative

Plant inv: the device was returned to the manufacturer for physical evaluation.A visual examination of the returned device revealed that the fibers were wet with indication of blood exposure.No cracks, damage, or irregularities were observed.The dialysate/blood ports were found to be undamaged and without defect.The polyurethane material remained intact and inspection of all molded components did not indicate any defects that would have caused improper mating between parts.Further examination of the fiber bundle did not reveal any damage or irregularities; specifically, no broken, kinked, looped, or damaged fibers.A review of the device manufacturing records was conducted by the manufacturer.There was no indication of product non-acceptance or deviation during the manufacturing process which could be associated with the reported event.The review included a check of non-conformances, rework, labeling, process controls, and any other occurrence in production potentially related to the complaint.Additionally, the dialyzer instructions for use (ifu) document cautions the user of potential hypersensitivity reactions including itching.The investigation into the cause of the patient incident was not able to confirm an issue which would have resulted in the adverse event.Analysis of the complaint device did not identify any damage, irregularities, or defects that would affect the integrity or performance of the dialyzer unit.Clinical inv: a clinical investigation was performed by a specialist to identify a causal relationship between the between the optiflux dialyzer and the adverse event.The clinician concluded that the documentation in the complaint file supports a probable association between the optiflux 180nre dialyzer assembly and the itchiness.Specifically in light of the fact that once the dialyzer was changed to the optiflux 180nr, there were no further reports of patient itching.

• 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; 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: 6555526
• MDR Text Key: 74789058
• Report Number: 1713747-2017-00130
• Device Sequence Number: 1
• Product Code: KDI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 0500318E
• Device Lot Number: 17BU03011
• Other Device ID Number: 00840861100156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 118