MAUDE Adverse Event Report: ST. WENDEL AG ULTRAFLUX AV 1000 S; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 01-8981-0

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2022

Event Type  malfunction  

Event Description

It was reported to fresenius that this critically ill patient on continuous veno-venous hemodialysis (cvvhd) therapy on the multifiltratepro with the ultraflux av 1000s hemofilter experienced a potential clogging event within the multifiltratepro system.An allegation exists stating this event involved the performance of the ultraflux av 1000s in the initial reporting.Fresenius received a report stating this patient with 2nd and 3rd degree burns on 70% of body surface area was hospitalized and placed on cvvhd on (b)(6) 2022, presumably to support renal function while critically ill.The patient required a consumable exchange, including the ultraflux av 1000s.The need for the consumable exchange was not reported; however, there was no indication this exchange was due to any deleterious effects to the patient.Through the course of cvvhd therapy, the fibrogammin administration, tranexamic acid indication, propofol administration as well as the patient¿s triglycerides and albumin were all observed.It was determined that a potential clogging event occurred in the multifiltratepro system involving the ultraflux av 1000s hemofilter based on the local clinicians¿ observations.The clinicians¿ alternative theory of the suspected clogging event involved the use of hemosol b0 solution that was consistent with operator error, yet this was not confirmed.Further information including patient demographics, specific laboratory values, patient disposition following cvvhd therapy and causality of the suspected clogging event were not reported.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: in the information provided, though a suspected clogging event occurred during cvvhd therapy, there was no indication this patient experienced an adverse event or serious injury related to the clogging event.Additionally, medical intervention for this event was not reported and there was no indication any medical intervention was provided to reverse any harmful effects of the suspected clogging.Based on the available information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product.

Event Description

It was reported to fresenius that this critically ill patient on continuous veno-venous hemodialysis (cvvhd) therapy on the multifiltratepro with the ultraflux av 1000s hemofilter experienced a potential clogging event within the multifiltratepro system.An allegation exists stating this event involved the performance of the ultraflux av 1000s in the initial reporting.Fresenius received a report stating this patient with 2nd and 3rd degree burns on 70% of body surface area was hospitalized and placed on cvvhd on 29/mar/2022, presumably to support renal function while critically ill.The patient required a consumable exchange, including the ultraflux av 1000s.The need for the consumable exchange was not reported; however, there was no indication this exchange was due to any deleterious effects to the patient.Through the course of cvvhd therapy, the fibrogammin administration, tranexamic acid indication, propofol administration as well as the patient¿s triglycerides and albumin were all observed.It was determined that a potential clogging event occurred in the multifiltratepro system involving the ultraflux av 1000s hemofilter based on the local clinicians¿ observations.The clinicians¿ alternative theory of the suspected clogging event involved the use of hemosol b0 solution that was consistent with operator error, yet this was not confirmed.Further information including patient demographics, specific laboratory values, patient disposition following cvvhd therapy and causality of the suspected clogging event were not reported.

Manufacturer Narrative

Plant investigation:.The cause for the failure reported cannot be confirmed based on the current available information.In the past for similar cases, extraction of retain samples showed no unusual residuals which could lead to the reported reaction.Lots are subject to 100% testing prior to release.It is highly unlikely that a failure would be detected during evaluation of another retention sample.This described situation is included within the instruction for use (ifu) and product labeling.A batch record review was also performed.No indication for any relationship with the reported failure mode has been found during the review.Therefore, it is assumed that the patient allergy/reaction might be caused by other factors besides dialyzer, for example, the specific physical/medical status of patient.

Manufacturer Narrative

Correction: h10 (expanding upon initial plant investigation) plant investigation: the reported complaint could not be confirmed.The complaint sample was not available to be returned for evaluation.Due to 100% testing, it is highly unlikely to detect a failure in the retention sample.Furthermore, only a small number of reserve samples is available.Therefore the retention sample analysis is not done.The cause for the failure reported cannot be confirmed based on the current available information.In the past for similar cases, extraction of retain samples showed no unusual residuals which could lead to the reported reaction.Therefore, it is assumed that the patient allergy/reaction might be caused by other factors besides dialyzer, for example, the specific physical/medical status of patient.A review of the instruction for use (ifu) and/or label indicated that the described situation is adequately addressed.A batch record review confirmed that the products have been inspected according to the inspection protocol and were found to be conforming to specifications.No indication for any relationship with the reported failure mode has been found during the review.Based on the information available, the cause of the reported failure could not be traced to the device.

Event Description

It was reported to fresenius that this critically ill patient on continuous veno-venous hemodialysis (cvvhd) therapy on the multifiltratepro with the ultraflux av 1000s hemofilter experienced a potential clogging event within the multifiltratepro system.An allegation exists stating this event involved the performance of the ultraflux av 1000s in the initial reporting.Fresenius received a report stating this patient with 2nd and 3rd degree burns on 70% of body surface area was hospitalized and placed on cvvhd on 29/mar/2022, presumably to support renal function while critically ill.The patient required a consumable exchange, including the ultraflux av 1000s.The need for the consumable exchange was not reported; however, there was no indication this exchange was due to any deleterious effects to the patient.Through the course of cvvhd therapy, the fibrogammin administration, tranexamic acid indication, propofol administration as well as the patient¿s triglycerides and albumin were all observed.It was determined that a potential clogging event occurred in the multifiltratepro system involving the ultraflux av 1000s hemofilter based on the local clinicians¿ observations.The clinicians¿ alternative theory of the suspected clogging event involved the use of hemosol b0 solution that was consistent with operator error, yet this was not confirmed.Further information including patient demographics, specific laboratory values, patient disposition following cvvhd therapy and causality of the suspected clogging event were not reported.

• Brand Name: ULTRAFLUX AV 1000 S
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): ST. WENDEL AG; fmc deutschland gmbh; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer (Section G): ST. WENDEL AG; fmc deutschland gmbh; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 14491074
• MDR Text Key: 300446838
• Report Number: 3002807005-2022-00015
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01-8981-0
• Device Lot Number: C2BE3100
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 01/06/2023
• 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: FRESENIUS MULTIFILTRATE SYSTEM; FRESENIUS MULTIFILTRATE SYSTEM; FRESENIUS MULTIFILTRATE SYSTEM