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

Model Number 0500318E

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

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); Hypervolemia (2664)

Event Date 03/30/2022

Event Type  Injury  

Event Description

It was reported that a hemodialysis (hd) patient experienced oxygen (o2) desaturation (70%), dyspnea, and hypotension during hd therapy on 30/mar/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 first treatment that was initiated at 06:15.).

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.

Manufacturer Narrative

Additional information: g1 plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.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.Twelve lots were found to have been delivered in this time period.A production records review was performed on the reported lots.An investigation of the device history records (dhr) was conducted by the manufacturer.There were two lots with one approved temporary deviation notice (dn) and one lot with a non-conformance (nc).They were all unrelated to the reported complaint event.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lots met all release criteria.The optiflux dialyzer instruction for use (ifu) was reviewed.The ifu indicates the following: ¿in rare cases, thrombocytopenia or hypersensitivity reactions including anaphylactic or anaphylactoid reactions to the dialyzer, or other elements in the extracorporeal circuit, may occur during hemodialysis.Hypersensitivity reactions may cause mild to severe signs and symptoms, including itching, flushing, hives, swelling, fever, leukopenia, hypotension, hypertension, shortness of breath with wheezing, arrhythmias, and/or respiratory arrest.Patients with a history of hypersensitivity reactions or patients who have a history of being highly sensitive and allergic to a variety of substances should be carefully monitored during treatment.¿ a definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

Event Description

It was reported that a hemodialysis (hd) patient experienced oxygen (o2) desaturation (70%), dyspnea, and hypotension during hd therapy on 30/mar/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 30/mar/2022 without issue.(this report captures the first treatment that was initiated at 06:15.).

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 first treatment that was initiated at 06:15.).

Manufacturer Narrative

Correction: h6; c50591 was inadvertently omitted as a health effect - clinical code in the initial submission.

• 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; 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 Key: 14215012
• MDR Text Key: 294647004
• Report Number: 0001713747-2022-00142
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0500318E
• Device Catalogue Number: 0500318E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 06/30/2022; 07/22/2022
• Supplement Dates FDA Received: 07/19/2022; 07/22/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 132 KG