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 Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Rash (2033); Swelling (2091); Convulsion, Tonic (2223); Reaction (2414); Loss of consciousness (2418)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

The post market surveillance department is in the process of reviewing patient medical records.The plant investigation is in process.A supplemental mdr will be submitted at the completion of these activities.

Event Description

A nurse at the user facility reported that a hemodialysis (hd) patient experienced an allergic reaction of unknown origin and various levels of severity while undergoing hd therapy using a fresenius optiflux 180nre dialyzer assembly product.The nurse revealed that the patient first experienced reactions on (b)(6) 2017.This submission captures the event associated with the patient¿s hd treatment performed on (b)(6) 2017.Follow-up provided by the patient¿s hd nurse revealed that the onset of the reaction symptoms vary and are described as being random in nature.The patient reactions have occurred prior to, during, and following the completion of the hd treatment.Additionally, the patient has experienced reactions at home, on days where no hd therapy was scheduled.Symptoms include welts/hives/rash all over body, itching, lips and facial swelling, raspy voice, nausea and vomiting, unstable or drop in blood pressure (no values provided), and convulsions.Normal saline boluses have been provided in the presence of fluid overload (specifics not provided).All of the documented symptoms have been experienced, however, the date, severity, and frequency of each occurrence is unknown.Although there are no dates associated with any of the noted symptoms, the medical records confirmed that the patient had a three day a week, monday, wednesday, friday, dialysis schedule.

Manufacturer Narrative

Plant inv.: the device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A manufacturing review was performed of the dialyzer products, from the reported catalog number (0500318e), shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.An investigation of the device manufacturing records was performed on the 6 lots identified.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.The lots passed all release criteria.A review of the batch production records did not reveal a probable cause for the customer complaint.However, the dialyzer instructions for use (ifu) document cautions the user regarding reactions.Clinical inv.: a clinical investigation was performed by a clinical specialist to identify a causal relationship between the optiflux 180nre dialyzer assembly and the adverse event.The clinical specialist concluded that a temporal relationship exists between the optiflux 180nre dialyzer and the patient reaction.However, a probable association between the optiflux dialyzer and the myriad of reactions the patient experienced cannot be determined based on the lack of available information.In addition, the patient continued to experience reactions of varying degrees after the dialyzer was switched to another manufacturer¿s product.Furthermore, the patient has a history of non-compliance with medications and diet, including consuming food where a known allergy exists.

• 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: 6508226
• MDR Text Key: 73328166
• Report Number: 1713747-2017-00112
• 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: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0500318E
• Other Device ID Number: 00840861100156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/17/2017
• 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
• Treatment: DIPHENHYDRAMINE 12.5MG IVP; DOXERCALCIFEROL (HECTORAL); HEPARIN 1000 U/ML CATH LOCK ART PORT 2000U POST TX; HEPARIN 1000 U/ML CATH LOCK VEN PORT 2100U POST TX; HEPARIN 1000 U/ML CATH SYST BOLUS 5000U IVP
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 117