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 Problem Itching Sensation (1943)

Event Date 03/22/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A user facility nurse reported that a patient complained of pruritis (itching) during hemodialysis (hd) therapy with the fresenius optiflux 180nre dialyzer, despite a full recirculation of normal saline (nacl) and one full liter of normal saline flushed through the dialyzer prior to the treatment.Follow-up medical treatment information was provided, which confirmed that the patient was administered benadryl (diphenhydramine) 25 mg intravenously (iv).The treatment information also reported that the patient complained of cramps in which the ultrafiltration (uf) rate was turned off and the patient was administered 50 ml of nacl with effect.The patient completed the scheduled hd treatment and was discharged to home in stable condition.No malfunction of the fresenius dialyzer in use during the hd treatment was alleged, observed, or identified prior to, during, or following the event.The complaint device has not been returned to the manufacturer for evaluation.

Manufacturer Narrative

The information supports a temporal association between the optiflux dialyzer and the reported itching.However, there is no documentation to support a causal relationship between the itching and the optiflux dialyzer.The use of the optiflux dialyzer (polysulfone membrane, electron beam sterilization) was changed to the baxter exeltra 150 (cellulose triacetate membrane, gamma irradiation sterilization), and the itching had reoccurred.Also, the patient was administered heparin during hemodialysis (hd) treatment.It is unknown if there is a potential heparin allergy.A temporal association with the fresenius 2008k hd machine and cramping during hd treatment exists; however, this only led to temporary discomfort, the patient was given 50ml normal saline, and the ultrafiltration rate was turned off.There was no allegation of product malfunction.The patient was discharged to home in stable condition and returned for the next scheduled hd treatment.The patient has continued with hd therapy for renal replacement therapy.Plant investigation: the device was not returned to the manufacturer and the lot was not provided.A definitive conclusion regarding the complaint cannot be reached without physical examination of the complaint device.A records review was conducted on 14 lots of fresenius dialyzers (catalog 0500318e) identified to have been shipped to this account from 6/30/2016 to 5/1/2017.Three lots were identified with one approved temporary deviation notice per lot and one lot was identified with one material containment hold; the lot was subsequently released.There was no non-conformance, deviation, rework, or process control issues which could be associated with the reported event.The records review did not reveal a probable cause for the complaint.Additionally, the dialyzer instructions for use (ifu) is included in each case of fresenius dialyzer product and cautions the user regarding reactions.

Event Description

Follow-up information with the patient¿s nurse revealed that the patient has regularly high potassium levels which is attributed to the patient¿s dietary intake.The patient has been repeatedly counseled on diet but continues to be non-compliant leading to the elevation of blood potassium level.

• 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: 6645594
• MDR Text Key: 77703058
• Report Number: 1713747-2017-00204
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0500318E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 60 YR
• Patient Weight: 69