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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/05/2022

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported to fresenius that this critically ill patient experienced abnormal laboratory values following a suspected clogging within the multifiltratepro system during continuous veno-venous hemodialysis (cvvhd) on the multifiltratepro with the ultraflux av 1000s hemofilter.An allegation was made involving the performance of the ultraflux av 1000s upon initial reporting.Fresenius received a report stating this patient suffering from child class b liver cirrhosis was hospitalized following elevated ammonia levels due to idiopathic postprandial syndrome (exact date of admission unknown).The patient was placed on cvvhd in the intensive care unit presumably to support renal function while critically ill.Through the course of cvvhd therapy, the patient required a ¿kit¿ exchange, indicating disposables were exchanged including the hemofilter.The reason for the initial consumable exchange was not reported; however, there was no indication the exchange was due to any deleterious effect to the patient.Laboratory findings taken approximately 18 hours following the consumable exchange indicated that the patient¿s calcium and calcium substitution began to show ¿atypical courses¿, as well as hypoalbuminemia with albumen levels of approximately 20 g/l (exact laboratory values not provided).Due to abnormal laboratory values, the time to determine patient¿s diagnoses was delayed.The cause of the abnormal laboratory values was attributed to a suspected clogging event within the ultraflux av 1000s hemofilter, yet this could not be confirmed.Cvvhd therapy was discontinued as the patient experienced auto diuresis (exact date not reported).No further information including patient demographics, specific laboratory values and causality of this event were not reported.

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 experienced abnormal laboratory values following a suspected clogging within the multifiltratepro system during continuous veno-venous hemodialysis (cvvhd) on the multifiltratepro with the ultraflux av 1000s hemofilter.An allegation was made involving the performance of the ultraflux av 1000s upon initial reporting.Fresenius received a report stating this patient suffering from child class b liver cirrhosis was hospitalized following elevated ammonia levels due to idiopathic postprandial syndrome (exact date of admission unknown).The patient was placed on cvvhd in the intensive care unit presumably to support renal function while critically ill.Through the course of cvvhd therapy, the patient required a ¿kit¿ exchange, indicating disposables were exchanged including the hemofilter.The reason for the initial consumable exchange was not reported; however, there was no indication the exchange was due to any deleterious effect to the patient.Laboratory findings taken approximately 18 hours following the consumable exchange indicated that the patient¿s calcium and calcium substitution began to show ¿atypical courses¿, as well as hypoalbuminemia with albumen levels of approximately 20 g/l (exact laboratory values not provided).Due to abnormal laboratory values, the time to determine patient¿s diagnoses was delayed.The cause of the abnormal laboratory values was attributed to a suspected clogging event within the ultraflux av 1000s hemofilter, yet this could not be confirmed.Cvvhd therapy was discontinued as the patient experienced auto diuresis (exact date not reported).No further information including patient demographics, specific laboratory values and causality of this event were not reported.

Event Description

It was reported to fresenius that this critically ill patient experienced abnormal laboratory values following a suspected clogging within the multifiltratepro system during continuous veno-venous hemodialysis (cvvhd) on the multifiltratepro with the ultraflux av 1000s hemofilter.An allegation was made involving the performance of the ultraflux av 1000s upon initial reporting.Fresenius received a report stating this patient suffering from child class b liver cirrhosis was hospitalized following elevated ammonia levels due to idiopathic postprandial syndrome (exact date of admission unknown).The patient was placed on cvvhd in the intensive care unit presumably to support renal function while critically ill.Through the course of cvvhd therapy, the patient required a ¿kit¿ exchange, indicating disposables were exchanged including the hemofilter.The reason for the initial consumable exchange was not reported; however, there was no indication the exchange was due to any deleterious effect to the patient.Laboratory findings taken approximately 18 hours following the consumable exchange indicated that the patient¿s calcium and calcium substitution began to show ¿atypical courses¿, as well as hypoalbuminemia with albumen levels of approximately 20 g/l (exact laboratory values not provided).Due to abnormal laboratory values, the time to determine patient¿s diagnoses was delayed.The cause of the abnormal laboratory values was attributed to a suspected clogging event within the ultraflux av 1000s hemofilter, yet this could not be confirmed.Cvvhd therapy was discontinued as the patient experienced auto diuresis (exact date not reported).No further information including patient demographics, specific laboratory values and causality of this event were not reported.

Manufacturer Narrative

Correction: h10 (clinical review) clinical review: in the information provided, though laboratory values presented in atypical ranges, there was no indication this patient experienced an adverse event or serious injury related to the abnormal laboratory values.Additionally, medical intervention for this event potentially included changing the hemofilter, disposables, and eventually discontinuing cvvhd therapy, yet there was no indication the medical intervention provided was 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 or other issue 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.

• Brand Name: ULTRAFLUX AV 1000 S
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): ST. WENDEL AG; fresenius deutschland gmbh; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer (Section G): ST. WENDEL AG; fresenius 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: 14487858
• MDR Text Key: 292501685
• Report Number: 3002807005-2022-00014
• 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: 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