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

Catalog Number 36-2013-0

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoxia (1918); Pneumonia (2011); Septic Shock (2068); Diabetic Ketoacidosis (2364); Respiratory Failure (2484); Insufficient Information (4580)

Event Date 11/21/2022

Event Type  Death  

Manufacturer Narrative

Plant investigation: no sample was returned for manufacturer evaluation.The reported failure type represents a known event.There was no treatment in the data recorded on (b)(6) 2022.Treatment data from 11/22/2022 was reviewed, and a communication error was found.A review of the device history record (dhr) was found to be unnecessary due to the fact that the failure/complaint can be clearly attributed to the failure mode ¿design¿.Based on all performed investigations/evaluations, the described failure could be reproduced.There can be many different root causes which lead to the 9040 error.The reported event is within the scope of a product improvement project.Further analyses are being carried out and further measures will be implemented in the next software versions.Some 9040 errors can be caused by problems of the pc board.Improvements to pc boards have been launched in production.Error memory entries which could be triggered by this problem include the following: systems record problems relating to the communication with the monitor, and a 9040.1 error displaying in the error memory.Technical information was published on 10/05/2022 which describes error diagnostics and troubleshooting in the cases of sporadic system crashes during operation and the correction (update bios) in the field.Based on the information available, the complaint was confirmed.A software problem was identified and the cause of the failure was traced to device design.

Event Description

It was reported that a technical stop of a multifiltrate pro machine occurred during a patient¿s continuous renal replacement therapy (crrt).Photos of the alarm messages that appeared were provided for review.The patient was reported to be very hemodynamically unstable, and they reportedly died.

Manufacturer Narrative

Additional information: h10 clinical investigation: it is unknown if a temporal relationship exists between crrt therapy utilizing the multifiltratepro and the patient¿s death as it was undetermined whether the patient was connected to the device at the time of this event.It is well established patients who are hemodynamically unstable on crrt in a critical care environment carry a high risk of mortality.The cause of the patient¿s death remains unknown.A report of device failure in relation to the patient¿s death has not been substantiated.In the absence of the required information, the cause of this patient¿s death and any relationship to the use of the multifiltratepro cannot be determined.Therefore, the multifiltratepro cannot 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

It was reported that a technical stop of a multifiltrate pro machine occurred during a patient¿s continuous renal replacement therapy (crrt).Photos of the alarm messages that appeared were provided for review.The patient was reported to be very hemodynamically unstable, and they reportedly died.

Manufacturer Narrative

Clinical investigation: it remains unknown if a temporal relationship exists between crrt utilizing the multifiltratepro and the patient¿s death, as a temporal relationship was not specifically stated.It is well established patients on crrt in critical care carry a high risk of mortality, particularly in the environment of hemodynamic instability as seen with this case.The cause of the patient¿s death was not provided.A report of device failure in relation to the patient¿s death has not been substantiated and no evidence was provided to confirm the patient expired due to the inability to reinfuse blood or any occurrence of hypovolemia.Due to the lack of patient information, in particular the unreported age and weight of this patient, any amount of reported blood loss cannot be determined to have deleterious effect.In the absence of the required information, the cause of this patient¿s death and any relationship to the performance of the multifiltratepro cannot be determined.Therefore, the multifiltratepro cannot be excluded as a potential 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

Additional information regarding the event was received.A critically ill patient was admitted to the intensive care unit (icu) on (b)(6) 2022 for acute respiratory distress syndrome (ards) with hypoxiemic pneumonia complicated with septic shock.The patient was on extracorporeal membrane oxygenation (ecmo) support (unknown brand and model of device), presumably to address the hypoxemia.The patient was placed on continuous venovenous hemodiafiltration (cvvhdf) utilizing the multifiltratepro device in tandem with ecmo support in efforts to resolve the patient¿s metabolic acidosis.Detailed information on the treatment parameters was not provided.Approximately half an hour after the cvvhdf treatment was initiated, a technical stoppage of the multifiltratepro machine occurred.Prior to the machine stopping, the following error codes appeared on the screen: failure 9040.1 and failure 9102.1.The touch screen was not responding despite the machine still being on, and blood was no longer circulating.At that point in time, the machine was powered down, and the tubing set was discarded without manual reinfusion of the extracorporeal blood to the patient, resulting in the patient¿s blood loss.A new cvvhdf treatment was initiated utilizing a new tubing set.The patient expired the following day, on (b)(6) 2022 at 11:44 pm local time.The cause of death or any temporal relationship between crrt therapy utilizing the multifiltratepro and this event were not reported and remain unknown.

• 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: 16355206
• MDR Text Key: 309309443
• Report Number: 0001225714-2023-00001
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 36-2013-0
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 02/21/2023; 03/30/2023
• Supplement Dates FDA Received: 02/23/2023; 04/24/2023
• 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): Death
• Patient Sex: Female