MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT F3 DIALYZER FINISHED ASSY; DIALYZER, CAPILLARY, HOLLOW FIBER

Model Number	0520165A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: the clinical investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
It was reported to fresenius that a patient developed fever (unknown reading), agitation, low blood pressure (reading not available) and tachycardia (result not available) during rinseback of a hemodialysis (hd) treatment.The patient received dialysis with a f3 dialyzer.The patient was premedicated with albumin flush of the dialyzer and iv methylprednisolone 10 mg iv.The patient was treated with saline administration and another dose of iv methylprednisolone.The patient also received prophylactic antibiotic (unknown medication).However, the doctor said blood cultures which were obtained, the same day showed the patient did not have an infection.Subsequently, the patient continued dialysis with f3 dialyzers from different lot (unavailable) (doctor said no other dialyzer small enough for pt.Needs) and the patient was premedicated ½ hour before treatment with ketorolac (dose unknown) iv, 20 mg methylprednisolone iv (increase in dose) and albumin flush of the dialyzer and the patient did not have any further reactions.The doctor confirmed this patient since received a kidney transplant and is no longer on dialysis.No further information is available.
Event or Problem Description
It was reported to fresenius that a patient developed fever (unknown reading), agitation, low blood pressure (reading not available) and tachycardia (result not available) during rinseback of a hemodialysis (hd) treatment.The patient received dialysis with a f3 dialyzer.The patient was premedicated with albumin flush of the dialyzer and iv methylprednisolone 10 mg iv.The patient was treated with saline administration and another dose of iv methylprednisolone.The patient also received prophylactic antibiotic (unknown medication).However, the doctor said blood cultures which were obtained, the same day showed the patient did not have an infection.Subsequently, the patient continued dialysis with f3 dialyzers from different lot (unavailable) (doctor said no other dialyzer small enough for pt.Needs) and the patient was premedicated ½ hour before treatment with ketorolac (dose unknown) iv, 20 mg methylprednisolone iv (increase in dose) and albumin flush of the dialyzer and the patient did not have any further reactions.The doctor confirmed this patient since received a kidney transplant and is no longer on dialysis.No further information is available.
Additional Manufacturer Narrative
Clinical investigation: an association exists between hd treatment utilizing the fresenius hemoflow f3 dialyzer and the patient¿s adverse event of allergic/hypersensitivity reaction to the dialyzer (characterized in this patient by symptoms of fever, agitation, hypotension, and tachycardia).I is well-documented that patients on hemodialysis may experience hypersensitivity and allergic reactions to dialyzer membrane and/or sterilant of various types of dialyzers.Moreover, the hemoflow f3 dialyzer manufacturer instructions for use document that side effects of hypersensitivity reactions may occur with use of the product.
Event or Problem Description
It was reported to fresenius that a patient developed fever (unknown reading), agitation, low blood pressure (reading not available) and tachycardia (result not available) during rinseback of a hemodialysis (hd) treatment.The patient received dialysis with a f3 dialyzer.The patient was premedicated with albumin flush of the dialyzer and iv methylprednisolone 10 mg iv.The patient was treated with saline administration and another dose of iv methylprednisolone.The patient also received prophylactic antibiotic (unknown medication).However, the doctor said blood cultures which were obtained, the same day showed the patient did not have an infection.Subsequently, the patient continued dialysis with f3 dialyzers from different lot (unavailable) (doctor said no other dialyzer small enough for pt.Needs) and the patient was premedicated ½ hour before treatment with ketorolac (dose unknown) iv, 20 mg methylprednisolone iv (increase in dose) and albumin flush of the dialyzer and the patient did not have any further reactions.The doctor confirmed this patient since received a kidney transplant and is no longer on dialysis.No further information is available.
Additional Manufacturer Narrative
Additional information: d9, h3 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 non-acceptance or deviation in the manufacturing process related to the complaint event.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production that was potentially related to the complaint.The lot met all release criteria.The hemoflow f3 dialyzer manufacturer instructions for use document that side effects of hypersensitivity reactions may occur with use of the product.It is well-documented that patients on hemodialysis may experience hypersensitivity and allergic reactions to dialyzer membrane and/or sterilant of various types of dialyzers.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.
Event or Problem Description
It was reported to fresenius that a patient developed fever (unknown reading), agitation, low blood pressure (reading not available) and tachycardia (result not available) during rinseback of a hemodialysis (hd) treatment.The patient received dialysis with a f3 dialyzer.The patient was premedicated with albumin flush of the dialyzer and iv methylprednisolone 10 mg iv.The patient was treated with saline administration and another dose of iv methylprednisolone.The patient also received prophylactic antibiotic (unknown medication).However, the doctor said blood cultures which were obtained, the same day showed the patient did not have an infection.Subsequently, the patient continued dialysis with f3 dialyzers from different lot (unavailable) (doctor said no other dialyzer small enough for pt.Needs) and the patient was premedicated ½ hour before treatment with ketorolac (dose unknown) iv, 20 mg methylprednisolone iv (increase in dose) and albumin flush of the dialyzer and the patient did not have any further reactions.The doctor confirmed this patient since received a kidney transplant and is no longer on dialysis.No further information is available.

• Brand Name: F3 DIALYZER FINISHED ASSY
• Common Device Name: DIALYZER, CAPILLARY, HOLLOW FIBER
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• MDR Report Key: 11848096
• Report Number: 1713747-2021-00153
• Device Sequence Number: 11640265
• Product Code: FJI
• UDI-Device Identifier: 00840861100019
• UDI-Public: 00840861100019
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K874872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/26/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 0520165A
• Device Catalogue Number: 0520165A
• Device Lot Number: 20AU04016
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 05/24/2021; 06/11/2021; 07/06/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/11/2021; 06/22/2021; 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 MO