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 Fever (1858); Hypersensitivity/Allergic reaction (1907); Chills (2191)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: chills or tremors of any etiology with no indication of medical intervention or resulting serious injury does not constitute a deleterious event to the patient.Additionally, 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.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 reactions.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported to fresenius that this patient on hemodialysis (hd) therapy utilizing the optiflux 180nre dialyzer experienced fever and chills upon the initiation of treatment.No medical intervention was provided at the time of the event however the nephrologist ordered a non-fresenius brand dialyzer be used for treatment.Multiple attempts were made to acquire further details concerning these allergic reaction; however, no additional information was obtained.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.

Event Description

It was reported to fresenius that this patient on hemodialysis (hd) therapy utilizing the optiflux 180nre dialyzer experienced fever and chills upon the initiation of treatment.No medical intervention was provided at the time of the event however the nephrologist ordered a non-fresenius brand dialyzer be used for treatment.Multiple attempts were made to acquire further details concerning these allergic reaction; however, no additional information was obtained.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.

Manufacturer Narrative

Clinical investigation: no parts were returned to the manufacturer and a lot was not provided.The clinical manager reported the events on behalf of the patient and no patient or clinic identifiers were provided, therefore an order history search could not be performed to identify specific dialyzer lot numbers.Likewise, a batch production review for the potential lot numbers involved in the complaint event was unable to be conducted.The complaint event is not confirmed as a definitive conclusion regarding the complaint incident cannot be reached based on the information provided.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.¿.

Event Description

It was reported to fresenius that this patient on hemodialysis (hd) therapy utilizing the optiflux 180nre dialyzer experienced fever and chills upon the initiation of treatment.No medical intervention was provided at the time of the event however the nephrologist ordered a non-fresenius brand dialyzer be used for treatment.Multiple attempts were made to acquire further details concerning these allergic reaction; however, no additional information was obtained.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.

Manufacturer Narrative

Correction: h6 (health effect impact code, type of investigation), h10 (plant investigation improperly labeled on followup #1) plant investigation: no parts were returned to the manufacturer and a lot was not provided.The clinical manager reported the events on behalf of the patient and no patient or clinic identifiers were provided, therefore an order history search could not be performed to identify specific dialyzer lot numbers.Likewise, a batch production review for the potential lot numbers involved in the complaint event was unable to be conducted.The complaint event is not confirmed as a definitive conclusion regarding the complaint incident cannot be reached based on the information provided.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.¿.

• 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: 15458497
• MDR Text Key: 300299928
• Report Number: 0001713747-2022-00368
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• 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
• Device Age: MO
• Date Manufacturer Received: 10/07/2022
• 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): Required Intervention