• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F180NRE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OGDEN MANUFACTURING PLANT OPTIFLUX F180NRE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number OPTIFLUX F180NRE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Fever (1858); Hypersensitivity/Allergic reaction (1907); Weakness (2145); Shaking/Tremors (2515); Confusion/ Disorientation (2553); Hematuria (2558)
Event Date 01/16/2018
Event Type  Injury  
Manufacturer Narrative
A temporal relationship exists between hd therapy, the optiflux 180 nre dialyzer and the reported adverse event(s), fever, shakiness, confusion and bloody urine after receiving hd. A follow-up e-mail from the dqp on (b)(6) 2018 indicated this patient ¿ended up in a hemolytic state. ¿ however the hospital records received for this patient do not provide any indication the patient was in a hemolytic state. According to the e-mail from (b)(6) 2018, the two patients reportedly do not utilize congruent hd staff, hd machines, hd dialyzer types or sizes, dialysate mixtures, dialysate mode of delivery, and/or presenting symptoms. Additionally, it was reported a different dialyzer was utilized while receiving hd on (b)(6) 2018, however the records only indicate the use of the optiflux 180nre. Based on the available information, causality cannot be determined. There is however, no documentation or evidence to indicate any fresenius device(s) malfunctioned or did not function as expected. A supplemental report will be submitted upon completion of the plant¿s investigation.
 
Event Description
Additional information solicited and received. Information in the complaint file and 13 pages of received records were reviewed. Director of quality and performance (dqp) improvement reported this patient with end stage renal disease (esrd) on hd for renal replacement therapy (rrt) was hospitalized on (b)(6) 2018 through (b)(6) 2018 for shakiness, confusion and bloody urine after receiving hd (timelines unknown). The patient was transported (mode of transportation unknown) to the emergency room (er) and was found to be in a hemolytic state (details unknown). Medical records indicate the patient was sent from the outpatient dialysis clinic with a fever (value unknown) and blood in urine (details unknown). The patient reported feeling ¿woozy¿ (timeline unknown), and has been feeling weak for a ¿couple weeks. ¿ additionally, the patient and wife reported the patient has been falling frequently (details unknown) at home. An electrocardiogram was performed in the er which showed normal sinus rhythm. Computerized topography (ct) of the brain was negative. Ct of the abdomen and pelvis revealed a diverticulitis in the large sigmoid colon, for which the patient was prescribed ciprofloxacin and flagyl (dosage, route, duration and frequency unknown). The patient was ¿gently hydrated¿ (details unknown) upon arrival to the er. No further details regarding the hospitalization are available. However, the discharge diagnoses listed in the received medical records were syncope, esrd and diverticulitis. Additionally, antibiotic therapy was discontinued after discharge. The patient returned to the ichd unit on (b)(6) 2018 for their next scheduled treatment. The dqp reported they used a ¿different dialyzer¿ (type unknown) and the treatment performed on (b)(6) 2018 occurred without incident. The patient was utilizing an optiflux 180nre dialyzer, and loop based dialysate (value
=
2. 0 k+ / 2. 5 ca) on the date of the event(s).
 
Manufacturer Narrative
The alleged event is not confirmed. The device was not returned to the manufacturing plant for investigation. As no lot number was provided for this complaint, a search was performed to obtain all lot numbers with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date. As a result, 13 lot numbers were found to be delivered to the customer in this time period. During the lot history review of the 13 lots, three lots were noted to have complaints reported against them. Two complaints were internal blood leaks and one for an external blood leak. No complaints related to a patient reaction have been reported against any of the 13 lot numbers. The production record for each lot identified on the sap search of delivered dialyzers to the customer was reviewed. Nine lots had one approved temporary dn on each, three lots had multiple approved temporary dns on each and one lot had multiple approved temporary dns and an ncr. They are 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 lot numbers passed pyrogen testing, were within sterilization dosage parameters and passed all release criteria.
 
Event Description
". ".
 
Event Description
". ".
 
Manufacturer Narrative
Lot number: unknown. A supplemental report will be submitted upon completion of the plant¿s investigation.
 
Event Description
Clinic reported that the lot number used during the alleged event is unknown.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the plant¿s investigation.
 
Event Description
Information received via an external email reported an adverse events at the hemodialysis facility, patient experienced dizziness, blood in the urine, and was admitted to the hospital. Additional information was solicited.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOPTIFLUX F180NRE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OGDEN MANUFACTURING PLANT
475 west 13th street
ogden UT 84404
MDR Report Key7251347
MDR Text Key195191328
Report Number1713747-2018-00054
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberOPTIFLUX F180NRE
Device Catalogue Number0500318E
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received07/23/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/08/2018 Patient Sequence Number: 1
Treatment
ACETAMINOPHEN (AS NEEDED ¿ PAIN/FEVER).; DOXAZOSIN; LOPRESSOR AND TAMSULOSIN HCL; NORVASC
-
-