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

Model Number MULTIFILTRATE PRO MACHINE

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Hypovolemia (2243)

Event Date 02/14/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to fresenius that blood loss occurred during the patient's continuous venovenous hemodialysis (cvvh) on a multifiltrate pro machine.Error code 9048.1 was encountered at an unspecified point of treatment.Treatment was stopped suddenly.The patient's blood could not be returned.The patient's estimated blood loss (ebl) is approximately 200 ml.The patient was transferred to another machine in order to continue treatment.The patient¿s care team reported the patient was hemodynamically unstable prior to the serious adverse events and required a blood transfusion and fluid replacement due to the treatment stoppage.Attempts to obtain additional information (e.G., treatment record, machine repair records, hospital records, patient demographics) proved unsuccessful.

Event Description

It was reported to fresenius that blood loss occurred during the patient's continuous venovenous hemodialysis (cvvh) on a multi-filtrate pro machine.Error code 9048.1 was encountered at an unspecified point of treatment.Treatment was stopped suddenly.The patient's blood could not be returned.The patient's estimated blood loss (ebl) is approximately 200 ml.The patient was transferred to another machine in order to continue treatment.The patient¿s care team reported the patient was hemodynamically unstable prior to the serious adverse events and required a blood transfusion and fluid replacement due to the treatment stoppage.Attempts to obtain additional information (e.G., treatment record, machine repair records, hospital records, patient demographics) proved unsuccessful.

Manufacturer Narrative

Correction: h10: (clinical review) clinical investigation: a temporal relationship exists between cvvh utilizing the multi-filtrate pro, error code 9048.1, and the serious adverse event of blood loss, which required a blood transfusion and fluid replacement.The patient was actively undergoing treatment when the device alarm and blood loss event occurred.Causality was attributed to the device alarm preventing the return of the patient¿s extracorporeal blood.High-priority or critical alarms always put the device into ¿safe mode,¿ which prevents the continuation of treatment and/or blood return.Limited information was provided during follow-up which prevented a more comprehensive investigation.Based on the totality of the information available, the multi-filtrate pro machine cannot be excluded from having a causal or contributory role in the patient¿s blood loss event.It remains unknown if the multi-filtrate pro required repair following the serious adverse events, or if it has been returned to service.Additionally, due to the lack of hospital records, treatment records, and discharge summary, this clinical investigation cannot disassociate the device from the serious adverse events.Plant investigation: machine files were provided to the manufacturer for review.It was confirmed that a software error occurred which resulted in system error 9040.1.This error is a known event.This alarm is being considered within the scope of product improvement.Additional software revisions have been implemented in order to address some of the causes for this failure message to occur.A device history record (dhr) review is not required as the cause of the error can already be attributed to a design issue.According to the available information, treatment could continue once the machine was restarted.The instructions for use (ifu) was reviewed which describes manual infusion and indicates that it should always be possible in the event that the machine cannot return blood.

• 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: 18846653
• MDR Text Key: 337005873
• Report Number: 0001225714-2024-00018
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MULTIFILTRATE PRO MACHINE
• Device Catalogue Number: 36-2013-0
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/10/2024
• 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): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 80 KG