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 Problem Septic Shock (2068)

Event Date 08/19/2023

Event Type  Death  

Event Description

On 21/aug/2023, fresenius became aware this patient with kidney failure (kf) undergoing continuous venovenus hemodialysis (cvvhd) in the intensive care unit (icu) experienced a delay in care due to a multifiltrate pro machine internal communication error (code 9040).Follow-up documentation confirmed the patient was admitted to the intensive care unit (admission date/diagnosis not provided) and was about to undergo cvvhd when the multifiltrate pro machine malfunctioned (code 9040).Although the timeline/specifics were not provided, the patient was reportedly extremely ill (i.E., patient¿s ph = 6.8, cardiogenic/septic shock) and the delay of care caused the destabilization of the patient¿s condition.After approximately 20 minutes, an alternative multifiltrate pro machine was prepared and the patient¿s cvvhd treatment was initiated.The patient¿s condition slowly returned to baseline; however, the patient would later expire from septic shock on (b)(6) 2023.Despite the patient undergoing ccvhd when he expired, the documentation reported the patient¿s cause of death was septic shock and was unrelated to any fresenius device(s) and/or product(s).The documentation provided states the multifiltrate pro machine did not require repair following serious adverse events and has been returned to service.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship exists between cvvhd utilizing the multifiltrate pro machine, and the serious adverse event of death, as the patient was actively undergoing cvvhd therapy when he expired.Limited follow-up information detailing the patient¿s disposition and hospital course prevented a more comprehensive investigation.However, causality was attributed to the patient¿s underlying medical conditions (e.G., cardiogenic/septic shock), and not due to the patient¿s use of the multifiltrate pro.Septic shock is a life-threatening condition (mortality rating of 12-22%) and is primarily caused by severe bacterial infections.Based on the totality of the information available, the multifiltrate pro machine can be excluded from having a possible causal or contributory role in the patient¿s expiration.Although the initial multifiltrate pro malfunction caused a 20-minute delay in treatment initiation, there is no objective evidence indicating it caused patient harm.An alternative multifiltrate pro was obtained/set-up and the patient¿s treatment was successfully started.The patient subsequently expired as a result of his compromised health status and was unrelated to the utilization of the multifiltrate pro or the delay in treatment.

Manufacturer Narrative

Investigation: the review of the complaints revealed that the reported failure type represents a known event.A review of the device history record (dhr) is found to be not necessary due to the fact that the failure/complaint can be clearly attributed to the failure mode design.As the reported error code is a sporadic software problem, there is no relation to repair activity.Based on all performed investigations/evaluations the described behavior could be reproduced.The reported error code is a collective error code for all kinds of pgm (poisson, gaussian, and multiplicative miscalculation.There are many sources of pgm error.Pgm errors result in the described error on the dialysis machine.As this type of pgm error can be caused by different causes, there is currently not a single root cause.This error usually leads to the termination of the treatment and to the stop of the machine.After restarting the device, the treatment could be continued.Manual blood reinfusion should always be possible and is described in instructions for use (ifu).The reported error is considered within the scope of the product improvement.No hardware component is associated with this complaint therefore, no hardware / sample investigation was performed.There are no indications on the basis of received complaint information and all investigations that the product deficiency is related to falsification or an unauthorized configuration.The residual risk is broadly acceptable.

Event Description

On 21/aug/2023, fresenius became aware this patient with kidney failure (kf) undergoing continuous venovenus hemodialysis (cvvhd) in the intensive care unit (icu) experienced a delay in care due to a multifiltrate pro machine internal communication error (code 9040).Follow-up documentation confirmed the patient was admitted to the intensive care unit (admission date/diagnosis not provided) and was about to undergo cvvhd when the multifiltrate pro machine malfunctioned (code 9040).Although the timeline/specifics were not provided, the patient was reportedly extremely ill (i.E., patient¿s ph = 6.8, cardiogenic/septic shock) and the delay of care caused the destabilization of the patient¿s condition.After approximately 20 minutes, an alternative multifiltrate pro machine was prepared and the patient¿s cvvhd treatment was initiated.The patient¿s condition slowly returned to baseline; however, the patient would later expire from septic shock on (b)(6) 2023.Despite the patient undergoing ccvhd when he expired, the documentation reported the patient¿s cause of death was septic shock and was unrelated to any fresenius device(s) and/or product(s).The documentation provided states the multifiltrate pro machine did not require repair following serious adverse events and has been returned to service.

• 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: 17683472
• MDR Text Key: 322640671
• Report Number: 0001225714-2023-00070
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 10/02/2023

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: 36-2013-0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 10/02/2023
• 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
• Treatment: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYSATE; FRESENIUS DIALYSATE
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Sex: Male