MAUDE Adverse Event Report: ST. WENDEL AG ULTRAFLUX AV 600 S; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 5007361

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

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Low Oxygen Saturation (2477)

Event Date 11/18/2023

Event Type  Injury  

Event Description

On 20/nov/2023, a country complaint administrator reported to fresenius this female renal replacement therapy patient on hemodialysis (hd) utilizing the ultraflux av 600s dialyzer experienced an allergic reaction involving a desaturation in peripheral oxygen during an hd treatment.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the country complaint administrator, it was reported this patient experienced a peripheral oxygen desaturation of 87% with dyspnea during a hd treatment utilizing the ultraflux av 600s dialyzer on (b)(6) 2023.The patient was provided oxygen at 4 l/min and intravenous methylprednisolone at 80 mg.The patient¿s symptoms did not resolve following oxygen and iv steroids, so the hd treatment was discontinued.There was no patient blood loss reported with this incident.It was reported the patient experienced an allergic reaction with a different dialyzer prior to this event on 17/nov/2023.The patient has since transitioned to peritoneal dialysis for renal replacement therapy as she remains stable.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship exists between the use of the ultraflux av 600s dialyzer and the adverse event of a dialyzer reaction, characterized by peripheral oxygen desaturation and dyspnea.It is well documented that patients on any modality of hemodialysis may experience reactions involving non-biocompatibility due to the composition of dialyzer membranes of various types of dialyzers.The cause of this patient¿s adverse event can be attributed to her intrinsic physiological response to dialyzer use with no probable indication of fresenius product or device deficiency or malfunction.This is evidenced by a previous reaction on a different dialyzer with no previous indication of product deficiency or malfunction.Additionally, in the ultraflux av dialyzer model line instructions for use, it cautions users of the known risk of hypersensitivity during acute dialysis treatments.Therefore, a deficiency or malfunction of the ultraflux av 600s dialyzer can be excluded as a root cause or contributor to this patient¿s adverse event.Based on the available information, there was no allegation or objective evidence of any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.

Event Description

On (b)(6) 2023, a country complaint administrator reported to fresenius this female renal replacement therapy patient on hemodialysis (hd) utilizing the ultraflux av 600s dialyzer experienced an allergic reaction involving a desaturation in peripheral oxygen during an hd treatment.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the country complaint administrator, it was reported this patient experienced a peripheral oxygen desaturation of 87% with dyspnea during a hd treatment utilizing the ultraflux av 600s dialyzer on (b)(6) 2023.The patient was provided oxygen at 4 l/min and intravenous methylprednisolone at 80 mg.The patient¿s symptoms did not resolve following oxygen and iv steroids, so the hd treatment was discontinued.There was no patient blood loss reported with this incident.It was reported the patient experienced an allergic reaction with a different dialyzer prior to this event on 2023.The patient has since transitioned to peritoneal dialysis for renal replacement therapy as she remains stable.

Manufacturer Narrative

Investigation: the reported event is adequately addressed in the instructions for use (ifu) and/or on the label and the product deficiency is not related to falsification.The sample is not available.Due to 100% testing, it is highly unlikely to detect a failure in the retention sample.Furthermore, only a small number of reserved samples are available.Therefore, the retention sample analysis is not done.Device history record (dhr) review noted that products have been inspected according to the inspection protocol and were found conforming to specifications.No indication for any relationship with the reported failure mode has been found during review.Complaint history review revealed one other complaint regarding this batch.The cause of the failure reported cannot be confirmed based on the correction available information.

• Brand Name: ULTRAFLUX AV 600 S
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): ST. WENDEL AG; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer (Section G): ST. WENDEL AG; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18269064
• MDR Text Key: 329747749
• Report Number: 3002807005-2023-00050
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

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: 5007361
• Device Lot Number: C1BL09100
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2024
• 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
• Treatment: AV-SET POST-ONLINEPLUS 5008-R; AV-SET POST-ONLINEPLUS 5008-R; BIBAG 5008 650G; BIBAG 5008 650G
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 94 KG