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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 0500318N
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of consciousness (2418)
Event Date 04/04/2022
Event Type  Death  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity. Clinical investigation: a temporal relationship exists between hd therapy utilizing the fresenius optiflux 180nr dialyzer, and the serious adverse events of feeling unwell, loss of consciousness, pulselessness, and subsequent death. The death certificate, end-stage renal disease (esrd) death notification and autopsy report were unavailable during this investigation; therefore, the definitive etiology of the events cannot be firmly established. However, the patient was actively undergoing hd therapy when the events occurred. The esrd population continues to have significantly higher mortality (up to 30-fold higher), and fewer expected years of life when compared to the general population. Based on the totality of the information available, the fresenius optiflux 180nr dialyzer cannot be excluded from having a possible causal and/or contributory role in the patient¿s serious adverse events. While uncommon, hypersensitivity reactions are known to occur with the use of optiflux dialyzers and/or other elements in the extracorporeal circuit. Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model.
 
Event Description
It was reported that a hemodialysis (hd) patient ¿feeling unwell,¿ loss of consciousness, pulselessness, and subsequent death on (b)(6) 2022. The patient arrived at their outpatient dialysis clinic on (b)(6) 2022 for his regularly scheduled treatment, and the patient¿s pre-treatment vitals included a b/p
=
108/68 (sitting), 103/67 (standing), pulse
=
93 bpm, respirations
=
16 per min, temperature
=
96. 4, oxygen saturation
=
94% and a pre-treatment weight of (b)(6) kgs. The treatment was initiated at 6:18 am (ultrafiltration goal
=
3. 5 kgs as tolerated) and terminated at 6:23 am after the patient complained of not feeling well. While the registered nurse (rn) was assessing the patient, they became unresponsive (it is unknown if the patient¿s blood was returned) and a pulse could not be palpated. The patient was placed in the trendelenburg position, emergency medical services (ems) was contacted, and the code cart was retrieved. Cardiopulmonary resuscitative (cpr) measures were instituted, and an automated external defibrillator (aed) was applied. No shock was advised, and cpr was continued until ems arrived at 6:30 am. Ems coded the patient (specifics not provided) until 7:06 am at which time the patient was pronounced dead. The patient received a total of 1800 ml of ns during the code, and the 2008t hemodialysis machine was sequestered following the serious adverse events. During post-event functional compliance testing, the 2008t hemodialysis performed as expected per the manufacturers¿ specifications. Additionally, a review of the water validation testing did not reveal any abnormal values. The dialyzer used during treatment was reportedly available to be returned for evaluation.
 
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Brand NameOPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OGDEN MANUFACTURING PLANT
director, site quality
475 west 13th street
ogden UT 84404
Manufacturer (Section G)
OGDEN MANUFACTURING PLANT
director, site quality
475 west 13th street
ogden UT 84404
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key14215016
MDR Text Key290137170
Report Number0001713747-2022-00145
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002277
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0500318N
Device Catalogue Number0500318N
Device Lot Number21PU04012
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received06/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/26/2022 Patient Sequence Number: 1
Treatment
FRESENIUS 2008T MACHINE
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