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

Catalog Number 36-2013-0

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243)

Event Date 03/30/2023

Event Type  Injury  

Event Description

It was reported that a patient on continuous venovenus hemodialysis (cvvhd) experienced blood loss (x2) after encountering error code 9046.1 during treatment, which prevented the patient¿s extracorporeal blood from being returned.Follow-up documentation confirmed the patient was hospitalized and undergoing cvvhd therapy utilizing the multifiltrate pro, when an internal communication error (code 9046.1) occurred.The patient¿s treatment was immediately stopped, resulting in an estimated blood loss (ebl) of < 500 ml.Although the specifics are unknown, the patient¿s extracorporeal blood could not be returned.The multifiltrate pro was set-up a second time, and the device passed all pre-treatment testing.The patient¿s cvvhd treatment was restarted, however several hours later (specifics not provided) clinical staff encountered the same internal communication error resulting in additional blood loss of < 500 ml.The patient required fluid replacement (crystalloid solution, volume not provided) due to the hypovolemia and hypotension caused by the blood loss.Although the details regarding the patient¿s hospitalization are limited, it was reported the patient completed treatment utilizing a different multifiltrate pro without issue.To date, the device remains out-of-service and is available for manufacturer evaluation.

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, the internal communication errors (9046.1) encountered by the clinical staff, and the serious adverse events of hypotension and hypovolemia due to blood loss (2 events, same treatment, ebl <500 ml per/event), which required fluid replacement.The patient was actively undergoing treatment when the device alarms and blood loss events occurred.Causality was attributed to the device alarms preventing the return of the patient¿s extracorporeal blood.Based on the totality of the information available, the multifiltrate pro cannot be excluded from having a possible causal or contributory role in the patient¿s blood loss events.Without hospital records, machine repair logs, discharge summary, treatment records or a manufacturer evaluation of the suspect device, this clinical investigation cannot disassociate the device from the serious adverse events.

Event Description

It was reported that a patient on continuous venovenus hemodialysis (cvvhd) experienced blood loss (x2) after encountering error code 9046.1 during treatment, which prevented the patient¿s extracorporeal blood from being returned.Follow-up documentation confirmed the patient was hospitalized and undergoing cvvhd therapy utilizing the multifiltrate pro, when an internal communication error (code 9046.1) occurred.The patient¿s treatment was immediately stopped, resulting in an estimated blood loss (ebl) of < 500 ml.Although the specifics are unknown, the patient¿s extracorporeal blood could not be returned.The multifiltrate pro was set-up a second time, and the device passed all pre-treatment testing.The patient¿s cvvhd treatment was restarted, however several hours later (specifics not provided) clinical staff encountered the same internal communication error resulting in additional blood loss of < 500 ml.The patient required fluid replacement (crystalloid solution, volume not provided) due to the hypovolemia and hypotension caused by the blood loss.Although the details regarding the patient¿s hospitalization are limited, it was reported the patient completed treatment utilizing a different multifiltrate pro without issue.To date, the device remains out-of-service and is available for manufacturer evaluation.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: h3 plant investigation: although a sample was reported to be available for evaluation, to date no sample has been received.However, it was reported that a sample investigation was not performed because there is no hardware component associated with this complaint.Machine files were provided for review and evaluated.The reported failure type represents a known event.A communication error occurred which resulted in system error 9040.1.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 behavior could be reproduced.The 9040.1 error code is a collective error code for all kinds of pgm (poisson, gaussian, and multiplicative) miscalculation.There are several different root causes for a pgm error.A 9040.1 error usually leads to the termination of treatment.After restarting the device, the treatment can be continued.Manual blood reinfusion is described in the ifu and should always be possible.The reported event is within the scope of a product improvement.A software problem was identified, and the cause of the failure was traced to device design.Appropriate measures will be taken in an existing capa that was opened to address this issue.

Event Description

It was reported that a patient on continuous venovenus hemodialysis (cvvhd) experienced blood loss (x2) after encountering error code 9046.1 during treatment, which prevented the patient¿s extracorporeal blood from being returned.Follow-up documentation confirmed the patient was hospitalized and undergoing cvvhd therapy utilizing the multifiltrate pro, when an internal communication error (code 9046.1) occurred.The patient¿s treatment was immediately stopped, resulting in an estimated blood loss (ebl) of < 500 ml.Although the specifics are unknown, the patient¿s extracorporeal blood could not be returned.The multifiltrate pro was set-up a second time, and the device passed all pre-treatment testing.The patient¿s cvvhd treatment was restarted, however several hours later (specifics not provided) clinical staff encountered the same internal communication error resulting in additional blood loss of < 500 ml.The patient required fluid replacement (crystalloid solution, volume not provided) due to the hypovolemia and hypotension caused by the blood loss.Although the details regarding the patient¿s hospitalization are limited, it was reported the patient completed treatment utilizing a different multifiltrate pro without issue.To date, the device remains out-of-service and is available for manufacturer evaluation.

• 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: 16829542
• MDR Text Key: 314158648
• Report Number: 0001225714-2023-00027
• 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,Followup
• Report Date: 06/16/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 04/28/2023; 05/22/2023
• Supplement Dates FDA Received: 04/28/2023; 06/16/2023
• 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): Required Intervention