MAUDE Adverse Event Report: SCHWEINFURT MULTIFILTRATEPRO HDF; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 36-2438-0

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

Patient Problem Insufficient Information (4580)

Event Date 05/21/2022

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: it is unknown if a temporal relationship exists between crrt utilizing the multifiltratepro and the patient¿s death as it remains unknown whether the patient was connected to the device at the time of death.It is well established patients on crrt in a critical care environment have a high risk of mortality.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.Additionally, no information was provided concerning alternative attempts to reinfuse the patient mechanically or manually (as directed in the multifiltratepro instructions for use) prior to their death.In the absence of the required information, the cause of this patient¿s death and any relationship to the reported device failure 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, though an allegation exists stating this patient¿s death was related to the performance of the multifiltratepro, there is no objective evidence that any fresenius device deficiency or malfunction caused or contributed to this patient¿s adverse event.

Event Description

It was reported to fresenius via a manufacturer incident report (mir) that a patient on continuous renal replacement therapy (crrt) utilizing the multifiltratepro device expired following a failure of the console.During the middle of crrt treatment, it was reported the machine displayed a ¿9040.1¿ error code.The multifiltratepro stopped responding to command and could only be turned off with no blood reinfusion to the patient.During the event, the multifiltratepro emitted a continuous audible alarm that could not be turned off.A function test was performed without incident and the crrt treatment was resumed.Following a treatment time of approximately two to three hours, the error message occurred again and no reinfusion to the patient was provided.The patient was connected during both occurrences of the error message.After the second device error occurred, the patient was not reinfused, and they expired.It was reported the patient¿s death was related to the occurrences of the error messages, leading to device failure, as they were not reinfused with blood.Per the statement reported by the local clinical investigation team, "with the assumption that an av 1000 filter (largest av filter) was used with the cvvhd (continuous venovenous hemodialysis) system, there was a blood loss of 246 ml per application, for a total blood loss of 492 ml.A blood loss of approximately 500 ml does not normally result in death; it is approximately the amount of a blood donation.It is unknown why no blood transfusion was given." multiple attempts were made to acquire further details concerning this patient¿s death; however, no additional information was obtained.Presently, patient demographics, diagnoses, rationale for crrt therapy, events surrounding this event and cause of death remain unknown.

Manufacturer Narrative

Plant investigation: a review of similar complaints revealed that the reported failure type represents a known event.No hardware component is associated with this complaint.Therefore, no hardware / sample investigation was performed.A review of the instructions for use (ifu) was performed.The performing of a manual blood reinfusion is described in the ifu.A 100% final testing of each machine ensures that devices are delivered according to specification.Based on the analysis of the service reorder, the malfunction of the device could be reproduced.The error 9040 collects several errors which lead to 9040 errors.There could be different root causes.Due to similar complaints, a follow-up of these issues and first measures took place in software version 5.01 in a capa project.The problems are still considered within the scope of the product improvement.Further analyses are being carried out and further measures will be implemented with 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 with the e-code 0370.Based on the available information, the complaint has been confirmed.

Event Description

It was reported to fresenius via a manufacturer incident report (mir) that a patient on continuous renal replacement therapy (crrt) utilizing the multifiltratepro device expired following a failure of the console.During the middle of crrt treatment, it was reported the machine displayed a ¿9040.1¿ error code.The multifiltratepro stopped responding to command and could only be turned off with no blood reinfusion to the patient.During the event, the multifiltratepro emitted a continuous audible alarm that could not be turned off.A function test was performed without incident and the crrt treatment was resumed.Following a treatment time of approximately two to three hours, the error message occurred again and no reinfusion to the patient was provided.The patient was connected during both occurrences of the error message.After the second device error occurred, the patient was not reinfused, and they expired.It was reported the patient¿s death was related to the occurrences of the error messages, leading to device failure, as they were not reinfused with blood.Per the statement reported by the local clinical investigation team, "with the assumption that an av 1000 filter (largest av filter) was used with the cvvhd (continuous venovenous hemodialysis) system, there was a blood loss of 246 ml per application, for a total blood loss of 492 ml.A blood loss of approximately 500 ml does not normally result in death; it is approximately the amount of a blood donation.It is unknown why no blood transfusion was given." multiple attempts were made to acquire further details concerning this patient¿s death; however, no additional information was obtained.Presently, patient demographics, diagnoses, rationale for crrt therapy, events surrounding this event and cause of death remain unknown.

• Brand Name: MULTIFILTRATEPRO HDF
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• 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: 14880850
• MDR Text Key: 295106348
• Report Number: 0001225714-2022-00003
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

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: 36-2438-0
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 01/03/2023
• Supplement Dates FDA Received: 01/11/2023
• 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