MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500316E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 02/04/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between the patient¿s symptoms of chest tightness, shortness of breath/respiratory distress, and hypotension during hd treatment with the optiflux dialyzer which led to patient hospitalization.However, there is no objective evidence that a fresenius product deficiency or malfunction caused/contributed to the patient¿s event.The patient was reportedly short of breath prior to start of hd treatment which did not respond to nebulizer treatment or oxygen therapy.There is no evidence of a dialyzer reaction or report of fluid volume overload that could have contributed to the patient¿s symptoms of chest tightness or shortness of breath during the hd treatment.Moreover, the patient¿s incidence of low blood pressure during the hd treatment is probably related to administration of nitroglycerin for the patient¿s chest tightness as hypotension is a known side effect of the medication.The patient has a past medical history of severe asthma, unspecified cardiac defect and mitral valve regurgitation which are likely confounding factors for this event.The patient underwent unspecified cardiac surgery for mitral valve regurgitation and the cardiac defect during this hospitalization which is not associated with use of the optiflux dialyzer or any fresenius product.The patient continues hd treatment via fresenius products without further reported issue.

Event Description

On (b)(6) 2019, this patient presented to the hemodialysis clinic with difficulty breathing/shortness of breath prior to start of dialysis.The patient has a past medical history of severe asthma as well as an unspecified congenital heart defect, mitral regurgitation and prior suspected dialyzer reaction to the fresenius optiflux 180nre dialyzer (further investigated in a separate complaint).Due to the suspected dialyzer reaction, during dialysis setup the fresenius optiflux 180nre dialyzer was primed with 1 liter of normal saline, (per doctor orders).Per the nurse, the patient did a nebulizer treatment while in the waiting room.However, prior to dialysis treatment while the patient sat in the dialysis chair, he stated that he was not able to sit back in chair with his feet up and needed to sit upright with feet on the floor (due to difficulty breathing).The patient¿s dry weight is (b)(6); and the pre-dialysis weight was (b)(6) (which reportedly was an expected pre-dialysis weight for the patient).The nurse confirmed the patient¿s fluid removal goal was 2300ml for the treatment; as the patient has a maximum fluid removal order of 1.8 kg plus 500 ml (for saline in dialysis circuit) per treatment.Per the nurse, the patient¿s lungs were clear on auscultation and the patient did not have any other symptoms.There was no reported fluid volume overload.Hemodialysis treatment was initiated with a reported systolic blood pressure (bp) of 130 (diastolic bp unknown).It was reported the patient¿s oxygen saturation was 96% while on 2 liters of oxygen for shortness of breath.Approximately 30 minutes into treatment, the patient began to complain of chest tightness.Per the nurse, the patient¿s bp was 166/90, heart rate was 102 and fluid removal achieved was 300 cc.As a result, the patient was administered nitroglycerin (1 tablet) per standing orders, which reportedly relieved the patient¿s chest tightness.However, subsequently the patient¿s bp dropped to 82/56 and the hemodialysis staff stopped fluid removal during dialysis and administered a bolus of 250cc normal saline.It was reported the patient was appeared to be in respiratory distress as the patient had to lean forward to breathe.As a result, the patient¿s oxygen was increased to 4l; however, per the nurse the o2 sat reading dropped to 92%.As a result, the hemodialysis treatment was discontinued, and the patient was sent to the hospital via ambulance for further evaluation and was admitted.Reportedly, during hospitalization the patient underwent surgery for mitral valve regurgitation and closure of a congenital defect in his heart on (b)(6) 2019.Reportedly, the patient continued hemodialysis in the hospital using the revaclear dialyzer (not a fresenius product) and had some itching.As a result, the patient was ordered to be premedicated with 50 mg of benadryl and the dialyzer be flushed with 2 liters of saline before every hemodialysis treatment.On (b)(6) 2019, the patient was discharged from the hospital continuing outpatient hemodialysis with the fresenius 180 nre dialyzer with the above pre-treatment orders.The nurse confirmed the patient resumed his regularly scheduled hemodialysis on (b)(6) 2019 and completed treatment without any adverse effects.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  correction: the mdr submitted on (b)(6)2019 under 1713747-2019-00066 referencing an event date of (b)(6)2019 was submitted in error and should be disregarded.A corrected mdr will be submitted for this complaint.

Manufacturer Narrative

Additional information: upon further investigation, it was determined that the event reported on 1713747-2019-00066 was not a reportable event related to fmc products.There was no serious injury, adverse event, or reportable malfunction.There will be no further updates on 1713747-2019-00066.

• Brand Name: OPTIFLUX 160NRE 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
• MDR Report Key: 8378567
• MDR Text Key: 137427163
• Report Number: 1713747-2019-00066
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0500316E
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 63