MAUDE Adverse Event Report: SCHWEINFURT MULTIFILTRATE PRO MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 36-2013-0

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

Patient Problems Apnea (1720); Atrial Fibrillation (1729); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 01/31/2024

Event Type  Injury  

Event Description

It was reported to fresenius that this patient with an acute kidney injury (aki) on continuous venovenus hemodialysis [cvv(hd)] utilizing a multifiltrate pro for renal replacement therapy (rrt) experienced a ¿peri-arrest¿on (b)(6) 2024.Follow-up documentation revealed the patient was hospitalized on (b)(6) 2024 for the removal of a large renal cell carcinoma, partial nephrectomy, and an inferior vena cava (ivc) thrombectomy.Post-operatively, the patient was admitted to the intensive care unit (icu) due to anuria, aki, significant blood loss (volume not provided), elevated drain output, and a high norepinephrine requirement (questioned vasoplegic shock).The patient began undergoing cvvhd on (b)(6) 2024 and began to show signs of clinical improvement (e.G., extubated, decrease vasopressor requirements).However, later that evening the patient¿s condition began to deteriorate again (e.G., atrial fibrillation, increase in norepinephrine requirement).On (b)(6) 2024 at approximately 1:00 am (19 hours into treatment), the patient became hypotensive (mean arterial pressure = 33), and air bubbles were noted in the cvvhd circuit (device alarmed appropriately).The treatment was immediately discontinued, and the patient¿s extracorporeal blood was discarded (volume not provided).After discontinuing cvvhd, the patient was initially experiencing atrial fibrillation (heart rate = 150 bpm), however shortly after it began the patient became bradycardic, hypercapnic, apneic, and lost consciousness.The patient was given intravenous (iv) norepinephrine 500 mcg with good effect (patient did not arrest), and regained consciousness.An inspection of the cvvhd setup did not detect any air in the venous return line, nor in the patient¿s hd catheter (not a fresenius product); however, air was visualized in the ¿bubble trap.¿ as a result, the multifiltrate pro was taken out of service.The treatment was restarted at approximately 5:00 am, utilizing the same hd catheter and an alternate multifiltrate pro.However, after beginning the second treatment the patient¿s condition began worsening again (e.G., reintubation, acidosis, rising lactate level, statis inotrope requirement).As a result, the medical team requested a review of the machine alarms (six total) which occurred before the initial treatment was discontinued.The alarms were as follows, (1) ¿low access pressure¿ alarm, 45 minutes prior to discontinuation, (2) ¿high pre-filter pressure¿ alarm, pressures rising, probable circuit clotting, and (3-6) ¿level in bubble catcher has dropped¿ alarms.Following the review, the medical team determined an air embolism was unlikely, as the multifiltrate pro machine alarmed appropriately indicating the blood level in the bubble trap was dropping.It was reportedly unclear where the air entered the system, given the stable arterial and venous pressures.The second treatment continued until 9:00 am on (b)(6) 2024 when the patient began experiencing poor flow through the temporary hd catheter, and it was surgically replaced.A third treatment was initiated; however, no additional information was provided.When the icu medical team was asked to investigate the cause of the serious adverse events, it was felt the combination of norepinephrine, vasopressin, and milrinone in a patient whose fluid status was ¿uncertain¿ was the cause of the patient¿s deterioration.Additionally, a pulmonary artery (pa) catheter was inserted post-event and suggested continued ¿underfilling.¿.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship exists between cvvhd utilizing the multifiltrate pro machine, and the serious adverse events of hypotension (requiring multiple vasopressors to control), atrial fibrillation, bradycardia, apnea, and loss of consciousness, as the patient was undergoing cvvhd when the patient¿s condition began to worsen.Initially there was concern the patient¿s declining condition could have been caused by an air embolism.However, after reviewing the treatment data, the icu medical team attributed causality to a combination of the patient¿s norepinephrine, vasopressin, and milrinone requirements, and an uncertain fluid status.Although the machine repair logs are absent, it was noted the multifiltrate pro alarmed appropriately by preventing any air from entering the patient¿s vasculature system (air did not surpass bubble detector).Based on the totality of the information available, the multifiltrate pro machine can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused and/or contributed to the serious adverse events.Furthermore, there was no report or documentation provided which indicated a fresenius device(s) and/or product(s) failed to meet the users¿ expectations and/or the manufacturers¿ specifications.

Event Description

It was reported to fresenius that this patient with an acute kidney injury (aki) on continuous venovenus hemodialysis [cvv(hd)] utilizing a multifiltrate pro for renal replacement therapy (rrt) experienced a ¿peri-arrest¿on (b)(6) 2024.Follow-up documentation revealed the patient was hospitalized on (b)(6) 2024 for the removal of a large renal cell carcinoma, partial nephrectomy, and an inferior vena cava (ivc) thrombectomy.Post-operatively, the patient was admitted to the intensive care unit (icu) due to anuria, aki, significant blood loss (volume not provided), elevated drain output, and a high norepinephrine requirement (questioned vasoplegic shock).The patient began undergoing cvvhd on (b)(6) 2024 and began to show signs of clinical improvement (e.G., extubated, decrease vasopressor requirements).However, later that evening the patient¿s condition began to deteriorate again (e.G., atrial fibrillation, increase in norepinephrine requirement).On (b)(6) 2024 at approximately 1:00 am (19 hours into treatment), the patient became hypotensive (mean arterial pressure = 33), and air bubbles were noted in the cvvhd circuit (device alarmed appropriately).The treatment was immediately discontinued, and the patient¿s extracorporeal blood was discarded (volume not provided).After discontinuing cvvhd, the patient was initially experiencing atrial fibrillation (heart rate = 150 bpm), however shortly after it began the patient became bradycardic, hypercapnic, apneic, and lost consciousness.The patient was given intravenous (iv) norepinephrine 500 mcg with good effect (patient did not arrest), and regained consciousness.An inspection of the cvvhd setup did not detect any air in the venous return line, nor in the patient¿s hd catheter (not a fresenius product); however, air was visualized in the ¿bubble trap.¿ as a result, the multifiltrate pro was taken out of service.The treatment was restarted at approximately 5:00 am, utilizing the same hd catheter and an alternate multifiltrate pro.However, after beginning the second treatment the patient¿s condition began worsening again (e.G., reintubation, acidosis, rising lactate level, statis inotrope requirement).As a result, the medical team requested a review of the machine alarms (six total) which occurred before the initial treatment was discontinued.The alarms were as follows, (1) ¿low access pressure¿ alarm, 45 minutes prior to discontinuation, (2) ¿high pre-filter pressure¿ alarm, pressures rising, probable circuit clotting, and (3-6) ¿level in bubble catcher has dropped¿ alarms.Following the review, the medical team determined an air embolism was unlikely, as the multifiltrate pro machine alarmed appropriately indicating the blood level in the bubble trap was dropping.It was reportedly unclear where the air entered the system, given the stable arterial and venous pressures.The second treatment continued until 9:00 am on (b)(6) 2024 when the patient began experiencing poor flow through the temporary hd catheter, and it was surgically replaced.A third treatment was initiated; however, no additional information was provided.When the icu medical team was asked to investigate the cause of the serious adverse events, it was felt the combination of norepinephrine, vasopressin, and milrinone in a patient whose fluid status was ¿uncertain¿ was the cause of the patient¿s deterioration.Additionally, a pulmonary artery (pa) catheter was inserted post-event and suggested continued ¿underfilling.¿.

Manufacturer Narrative

Plant investigation: machine data was provided to the manufacturer for review.Error code 7500 was identified along with the message "level in bubble catcher has dropped, set level." it was noted that the error code was confirmed with "ok." the level in the bubble catcher was not changed, therefore error 7500 repeatedly recurred and was confirmed by the user.Treatment was ended via hard key.The problem with the level in the bubble catcher was never corrected.There is no indication from the provided data that the machine failed to perform as intended.

• Brand Name: MULTIFILTRATE PRO MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): SCHWEINFURT; hafenstrasse 9; schweinfurt 97424 ; GM 97424
• Manufacturer (Section G): SCHWEINFURT; hafenstrasse 9; schweinfurt 97424 ; GM 97424
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18677827
• MDR Text Key: 335026130
• Report Number: 0001225714-2024-00006
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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: 36-2013-0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 89 KG