MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT F4 DIALYZER PRODUCTION ASSY.; DIALYZER, CAPILLARY, HOLLOW FIBER

Model Number	0520161A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Malaise (2359)
Date of Event	04/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: based on the available information, there is a temporal and a likely causal relationship between the fresenius f4 dialyzer and the patient¿s not feeling well during hd treatments.Although rare, hypersensitivity or anaphylactoid reactions to dialyzers are a known risk during hemodialysis.The exposure of the patient¿s blood to a foreign substance present in the extracorporeal circuit is the result of an immunoallergic response.There is no evidence of a f4 dialyzer product deficiency or malfunction.Additionally, although the patient experienced an adverse reaction during treatment, there is no allegation of a product malfunction or deficiency related to this event.
Event or Problem Description
A user facility nurse manager reported that a hemodialysis (hd) patient had a change in their hd prescription due to a possible dialyzer reaction.The reaction was mild and did not require medical intervention during the treatment.The patient reported not feeling well at treatment initiation.They were given gum and candy as it was suspected the saline could be causing a bad taste for the patient.The patient reportedly completed their 2-hour scheduled hd treatment with no further issues.Following this treatment, the patient was switched to the fresenius f40 hemoflow dialyzer from the fresenius f4 dialyzer.The f4 dialyzer used for the treatment was reportedly unavailable to be returned for a physical evaluation.Dialyzer lot information and additional patient details were not provided.
Additional 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 instruction for use (ifu) included with the f4 dialyzers provides general information related to reactions, which indicates ¿in rare cases, hypersensitivity reactions to the dialyzer or other elements in the extracorporeal circuit may occur during hemodialysis.If a hypersensitivity reaction occurs, the source of the hypersensitivity should be identified and that component of the extracorporeal circuit should be excluded from future use in hemodialysis treatments for that patient.With severe reactions, dialysis must be discontinued and aggressive first-line therapy for hypersensitivity reactions must be initiated.The decision to return the patient¿s blood in the event of a hypersensitivity reaction is the decision of the physician.¿ 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
A user facility nurse manager reported that a hemodialysis (hd) patient had a change in their hd prescription due to a possible dialyzer reaction.The reaction was mild and did not require medical intervention during the treatment.The patient reported not feeling well at treatment initiation.They were given gum and candy as it was suspected the saline could be causing a bad taste for the patient.The patient reportedly completed their 2-hour scheduled hd treatment with no further issues.Following this treatment, the patient was switched to the fresenius f40 hemoflow dialyzer from the fresenius f4 dialyzer.The f4 dialyzer used for the treatment was reportedly unavailable to be returned for a physical evaluation.Dialyzer lot information and additional patient details were not provided.It was later reported that the patient was switched from the fresenius f4 dialyzer to the fresenius f40s steam sterilized dialyzer, not to the f40 hemoflow dialyzer.The lot numbers for both devices were provided.
Additional Manufacturer Narrative
Additional information: b5, d4 and h4 the plant investigation is still in process.A supplemental mdr will be submitted upon completion of this activity.

• Brand Name: F4 DIALYZER PRODUCTION 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: 10095025
• Report Number: 1713747-2020-00206
• Device Sequence Number: 17006260
• Product Code: FJI
• UDI-Device Identifier: 00840861100026
• UDI-Public: 00840861100026
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K874872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2020

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: 09/30/2021
• Device Model Number: 0520161A
• Device Catalogue Number: 0520161A
• Device Lot Number: 18LU04005
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 06/01/2020; 07/31/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 06/02/2020; 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 5008 CORDIAX MACHINE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR