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

Catalog Number 0500318E

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

Patient Problems Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Itching Sensation (1943); Swelling/ Edema (4577)

Event Date 03/13/2024

Event Type  Injury  

Manufacturer Narrative

Clinical review: presently there is no allegation or objective evidence indicating a serious injury, patient death, or other adverse event(s) occurred related to a fresenius product(s) or device(s) warranting further investigation.Additionally, there is no allegation a fresenius product(s) or device(s) deficiency or malfunction caused or contributed to the patient¿s allergic reaction.In the instructions for use in the optiflux series of dialyzers, it cautions users of the risk of hypersensitivity and/or allergic reactions as a result of dialyzer use.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A user facility registered nurse (rn) reported that a hemodialysis (hd) patient complained of itching, flushing and facial swelling during hemodialysis (hd) treatment with the optiflux dialyzer.Oxygen, diphenhydramine 50 mg via intra-venous push (ivp), and solu-medrol 125 mg via intramuscular (im) injection were administered.Treatment was discontinued, 911 was activated, and the patient was transported to the hospital via emergency medical services (ems).The patient was later released.Upon follow up with the patient¿s hd registered nurse, it was reported this patient experienced itching and flushing of the skin, facial swelling and hypertension approximately two hours into an hd treatment on (b)(6) 2024.The patient¿s symptoms were attributed to an allergic reaction to the optiflux 180 nre dialyzer.The patient¿s blood was returned, and the treatment was discontinued.Emergency services were activated as the patient was given a one-time intramuscular injection of solumedrol at 125 mg and a one-time bolus of intravenous diphenhydramine at 50 mg.The patient¿s symptoms began to resolve as they were transported to the emergency department by emergency services.The patient was held for observation and released to home on the same day with no hospital admission.It was explained the patient has a history of hypersensitivity and allergic reactions to the optiflux line of dialyzers and was prescribed the nipro cellentia dialyzer (not a fresenius product) as a more biocompatible product prior to this event.The patient was inadvertently set up with the optiflux 180 nre dialyzer by clinic staff on 13/mar/2024 which subsequently led to the patient¿s allergic reaction.The patient continues hd therapy on an in-center basis with the appropriate dialyzer without incident following this event.It was affirmed the patient did not experience a serious injury as a result of this allergic reaction.Additionally, it was confirmed the patient¿s allergic reaction, and the associated ed visit were not due to a deficiency or malfunction of any fresenius product(s) or device(s).

Event Description

A user facility registered nurse (rn) reported that a hemodialysis (hd) patient complained of itching, flushing and facial swelling during hemodialysis (hd) treatment with the optiflux dialyzer.Oxygen, diphenhydramine 50 mg via intra-venous push (ivp), and solu-medrol 125 mg via intramuscular (im) injection were administered.Treatment was discontinued, 911 was activated, and the patient was transported to the hospital via emergency medical services (ems).The patient was later released.Upon follow up with the patient¿s hd registered nurse, it was reported this patient experienced itching and flushing of the skin, facial swelling and hypertension approximately two hours into an hd treatment on 13/mar/2024.The patient¿s symptoms were attributed to an allergic reaction to the optiflux 180 nre dialyzer.The patient¿s blood was returned, and the treatment was discontinued.Emergency services were activated as the patient was given a one-time intramuscular injection of solumedrol at 125 mg and a one-time bolus of intravenous diphenhydramine at 50 mg.The patient¿s symptoms began to resolve as they were transported to the emergency department by emergency services.The patient was held for observation and released to home on the same day with no hospital admission.It was explained the patient has a history of hypersensitivity and allergic reactions to the optiflux line of dialyzers and was prescribed the nipro cellentia dialyzer (not a fresenius product) as a more biocompatible product prior to this event.The patient was inadvertently set up with the optiflux 180 nre dialyzer by clinic staff on 13/mar/2024 which subsequently led to the patient¿s allergic reaction.The patient continues hd therapy on an in-center basis with the appropriate dialyzer without incident following this event.It was affirmed the patient did not experience a serious injury as a result of this allergic reaction.Additionally, it was confirmed the patient¿s allergic reaction, and the associated ed visit were not due to a deficiency or malfunction of any fresenius product(s) or device(s).

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.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 lot met all release criteria.The optiflux dialyzer instruction for use 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.Continuous improvement is of the utmost importance to fresenius medical care as we strive to provide dialysis products of the highest quality to our patients.Reports of leaking product are investigated both individually as complaints, as well as via the nc/capa program, in order to assess and improve our products and processes.Capas for vision systems and blood leak reduction are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.

• 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: 18949663
• MDR Text Key: 338244055
• Report Number: 0001713747-2024-00216
• 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: K162488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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 Catalogue Number: 0500318E
• Device Lot Number: 23SU01012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2023
• 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
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS COMBISET BLOODLINES; FRESENIUS COMBISET BLOODLINES
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American