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. .
|
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.¿.
|