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U.S. Department of Health and Human Services

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

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OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 0500318E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Anxiety (2328)
Event Date 03/30/2022
Event Type  Injury  
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 180nre dialyzer, and the serious adverse events of oxygen desaturation (70%), dyspnea, hypotension, anxiety, and reported fluid overload, which required hospital evaluation and eventual admission. The treatment records indicated the patient was actively undergoing hd therapy during both outpatient hd treatments on (b)(6) 2022. Given the patient¿s vitals, the need for emergent discontinuation of therapy, hospitalization, and the patient¿s positive response to a change in dialyzer type (optiflux 180nr eto sterilization), it is reasonable to discern a hypersensitivity reaction likely occurred. Based on the totality of the information available, the fresenius optiflux 180nre 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 experienced oxygen (o2) desaturation (70%), dyspnea, and hypotension during hd therapy on (b)(6) 2022. During follow-up, the patient¿s nephrologist reported the patient experienced o2 desaturation, hypotension (blood pressure
=
74/51), and dyspnea during hd therapy. The patient¿s treatment record confirmed the patient arrived for treatment at approximately 06:00. The patient¿s pre-treatment vitals included a blood pressure (b/p)
=
115/66 (sit), 121/83 (stand), pulse
=
70 bpm, resp
=
16 per min, temp
=
97. 9 and a pre-weight of 138. 3 kgs (6. 30 kgs above edw). The treatment was initiated at 06:15 (ultrafiltrate 4. 0 kgs as tolerated) and was terminated at 06:27 after the patient reported being unable to breathe. It is unknown if the patient¿s blood was returned, however a 300 ml bolus of normal saline (ns) was administered. The patient¿s b/p was 117/78 when the event occurred, however after the termination of therapy the patient¿s b/p dropped to 74/50. The patient was placed in the t-burg position, an additional 300 ml of ns was infused, and 5 liters of o2 was applied for cyanosis (nose). The patient¿s o2 saturation improved to 84%, and the patient¿s b/p increased to 98/59. However, the patient remained slow to respond to verbal stimuli and the clinic called 911. By 06:29 the patient had received an additional 600 ml of ns, after which the patient¿s o2 saturation improved to 88%-92% and the patient reported feeling better. Ems arrived at 06:31 and the patient was transported to the hospital. Prior to being discharged from the dialysis clinic the patient was alert with a b/p of 110/73 and a pulse of 72. The discharge summary was unavailable; however, the patient¿s nephrologist reported the patient received a nebulizer treatment during transport and reportedly began feeling better. Upon arrival to the to the hospital, the patient¿s b/p had stabilized, and a chest x-ray revealed the patient was fluid volume overloaded. Despite these findings, the patient¿s o2 requirements improved (down to 2 liters) and the patient was discharged from the hospital. Following discharge, the patient returned home where they ate, completed some chores, and went shopping. Later the same day the patient returned to the dialysis clinic to resume hd treatment. The patient¿s pre-treatment vitals included a b/p
=
112/82 (sit), 115/77 (stand), pulse
=
78 bpm, resp
=
16 per min, temp
=
97. 1 and a pre-weight of 139. 1 kgs (7. 1 kgs above edw). The treatment was initiated at 14:01 (ultrafiltrate 3. 5 kgs as tolerated) and at 14:13 the patient began to complain of dyspnea and anxiety. The patient¿s ultrafiltration goal was reduced to 0. 5 kgs, 5 liters of oxygen was applied, and a 300 ml ns bolus was administered. The patient¿s last recorded b/p was 120/81, and after contacting the nephrologist, the treatment was terminated, and the patient was sent back to the hospital (unknown if blood was returned). Ems returned at 14:39 and transported the patient back to the hospital. Prior to being discharged from the dialysis clinic the patient was alert, b/p
=
117/85 (sit), 129/80 (stand), pulse
=
81, and o2 saturation
=
91%. Once hospitalized, the patient underwent a ct scan which was negative for a pulmonary embolus, however it was positive for congestive heart failure (chf) and a right-sided plural effusion. Additionally, the patient underwent an echocardiogram which revealed pulmonary hypertension and an ejection fraction of 55-65%. The patient was transferred to the icu where hd therapy was restarted utilizing an optiflux 180nr (eto sterilization) after priming the dialyzer with 1000 ml of ns. The patient reportedly tolerated the remainder of hd therapy on (b)(6) 2022 without issue. (this report captures the second treatment that was initiated at 14:01. ).
 
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Brand NameOPTIFLUX 180NRE DIALYZER FINISHED ASSY.
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
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key14215024
MDR Text Key290941111
Report Number0001713747-2022-00143
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002761
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
Report Date 04/26/2022
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 Number0500318E
Device Catalogue Number0500318E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received04/04/2022
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 Treatment Data
Date Received: 04/26/2022 Patient Sequence Number: 1
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