MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH ULTRAFLUX AV 1000 S; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 01-8981-0

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

Patient Problems Adult Respiratory Distress Syndrome (1696); Pneumonia (2011)

Event Date 04/07/2022

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between crrt treatment utilizing the ultraflux av 1000s filter and the patient event of death.However, there is no documentation in the complaint file to show a causal relationship between the death and use of the ultraflux av 1000s filter.The patient was reported to have acute respiratory distress syndrome (ards) and pneumonia with poor coagulation function.Patients requiring renal replacement therapy (rrt) performed as continuous venovenous haemodiafiltration (cvvhdf) encounter several complications including platelet consumption, electrolyte disturbances, and hypercoagulable state, potentially leading to an unfavorable outcome among those that are critically ill.The treatment included heparin although an initial dosage of the anticoagulant was not administered.It is not documented at which point the heparin was added.Several studies have shown that initiation of rrt has been associated with worsening thrombocytopenia indicating that nearly two-thirds of rrt patients experienced a platelet decrease within 72 hours of rrt initiation.The average decrease being 33%.According to communication from the hospital, the suspected cause of death was related to the patient¿s underlying disease process.Based on the available information and the understanding that the scientific studies show related complications of cvvhdf include platelet consumption and a hypercoagulable state in addition to the knowledge that patients requiring rrt that are critically ill potentially have unfavorable outcomes and with no evidence of a malfunction or defect, the ultraflux av 100s filter can be excluded as the cause of the patient¿s death.

Event Description

It was reported that a patient who was undergoing continuous renal replacement therapy (crrt) on (b)(6) 2022 expired.The patient¿s admitting diagnosis was not provided; however, it was documented that the patient¿s underlying diseases were acute respiratory distress syndrome (ards) and pneumonia with poor coagulation function.It is unknown if the patient required crrt prior to (b)(6) 2022.On (b)(6) 2022 it was documented that the patient¿s platelet count was 92x10¿9/l.The patient was initiated on crrt with continuous venovenous hemodiafiltration (cvvhdf) utilizing the fresenius multifiltrate machine with ultraflux av 1000s filter.Priming of the intramembrane was done with 700ml (normal saline) and the extra membrane filling was 300ml (normal saline).The blood flow rate was set to 150-180ml/min and the dialysate flow rate was set to 800-1200ml/min.No initial heparin dose was administered.Activated partial thromboplastin time (aptt) was controlled at about 70 seconds.During the treatment (time not provided), heparin was added at 125 units/hour.Pressure monitoring was performed.It was documented that arterial pressure gradually decreased, transmembrane pressure gradually increased, and venous pressure was approximately 30 at start then gradually increased during treatment.Approximately 2-3 hours after initiation of the patient¿s treatment, clotting began in the filter.Both the venous and arterial bubble catchers had visible clots of varying size.The machine did alarm with arterial and venous pressure alarms as well as tmp pressure alarm.During the treatment and use of the fresenius crrt, the monitoring of the patient¿s aptt was prolonged but the filter was still coagulated, and the patient had a significant decrease in platelet count.The patient¿s platelet count was recorded as 20x10¿9/l.The patient expired (time not provided).No additional patient information was available as the record was sealed.The hospital communicated that the suspected cause of death was the patient¿s underlying disease.No malfunction of the machine was reported.

Event Description

It was reported that a patient who was undergoing continuous renal replacement therapy (crrt) on (b)(6) 2022 expired.The patient¿s admitting diagnosis was not provided; however, it was documented that the patient¿s underlying diseases were acute respiratory distress syndrome (ards) and pneumonia with poor coagulation function.It is unknown if the patient required crrt prior to (b)(6) 2022.On (b)(6) 2022 it was documented that the patient¿s platelet count was (b)(6).The patient was initiated on crrt with continuous venovenous hemodiafiltration (cvvhdf) utilizing the fresenius multifiltrate machine with ultraflux av 1000s filter.Priming of the intramembrane was done with 700ml (normal saline) and the extramembrane filling was 300ml (normal saline).The blood flow rate was set to 150-180ml/min and the dialysate flow rate was set to 800-1200ml/min.No initial heparin dose was administered.Activated partial thromboplastin time (aptt) was controlled at about 70 seconds.During the treatment (time not provided), heparin was added at 125 units/hour.Pressure monitoring was performed.It was documented that arterial pressure gradually decreased, transmembrane pressure gradually increased, and venous pressure was approximately 30 at start then gradually increased during treatment.Approximately 2-3 hours after initiation of the patient¿s treatment, clotting began in the filter.Both the venous and arterial bubble catchers had visible clots of varying size.The machine did alarm with arterial and venous pressure alarms as well as tmp pressure alarm.During the treatment and use of the fresenius crrt, the monitoring of the patient¿s aptt was prolonged but the filter was still coagulated, and the patient had a significant decrease in platelet count.The patient¿s platelet count was recorded as (b)(6).The patient expired (time not provided).No additional patient information was available as the record was sealed.The hospital communicated that the suspected cause of death was the patient¿s underlying disease.No malfunction of the machine was reported.

Manufacturer Narrative

Plant investigation: the sample was not available for evaluation and no meaningful pictures were provided.Therefore, further analysis could not be performed.The described situation is adequately addressed in the instructions for use (ifu) and/or on the label.The cause for the reported failure cannot be confirmed based on the available information.The extraction of retention samples showed no unusual residuals which could lead to the reported reaction.Therefore, it is assumed that the patient allergy/reaction may have been caused by other factors besides the dialyzer, for example, the specific physical/medical status of the patient.A failure during the manufacturing process can be excluded based on the investigation.In the production line, the filters are 100% tested both for their tightness and for open fibers.A batch record investigation was conducted, and all released products were found to be conforming to specifications.No indication for any relationship with the reported failure mode was found during the review.Based on the information available, the cause for the reported failure could not be traced to the device.

• Brand Name: ULTRAFLUX AV 1000 S
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH; st. wendel plant; frankfurter strabe 6-8; st. wendel 66606 ; GM 66606
• Manufacturer (Section G): FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH; st. wendel plant; frankfurter strabe 6-8; st. wendel 66606 ; GM 66606
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 14957925
• MDR Text Key: 295504467
• Report Number: 3002807005-2022-00017
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

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: 01-8981-0
• Device Lot Number: C2BG07100
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 01/03/2023
• Supplement Dates FDA Received: 01/04/2023
• 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 MACHINE; FRESENIUS MULTIFILTRATE MACHINE
• Patient Outcome(s): Death
• Patient Age: 86 YR
• Patient Sex: Male