MAUDE Adverse Event Report: B. BRAUN AVITUM AG DIALOG+®; DIALYZER

Catalog Number	710200S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/30/2024
Type of Reportable Event	Death
Event or Problem Description
The customer reported that on (b)(6) 2024, a patient was hooked up to the dialog machine for dialysis treatment and 15 minutes into treatment, the patient's venous bloodline detached from his central venous catheter (cvc).The patient exsanguinated and coded.The patient was briefly resuscitated and transported to the hospital, which was about ¼ mile away from the dialysis center, where he coded a second time and expired.The patient was a 70-year-old male.He was not new to dialysis, but he was also not a long-term patient.His access was a cvc.The following questions were answered by the customer via email as follow-up information: how was the incident discovered? discovered by pct working with patient.What hospital was the patient transported to? (b)(6).What medical interventions were needed at the dialysis center and what was needed later at the hospital? cpr, clamping blood lines / intubation and blood administration.Did the machine alarm at the time of the event? yes - logs showed a venous alarm was silenced and a manual blood pressure was started.Can additional information be provided on the bloodline detachment.Specifically, where on the bloodline did the detachment occur? connection between cvc venous port and bloodlines not tight.Was there any visual damage or issue identified with the bloodline.No.Is the bloodline batch available? if so, can it be provided? yes - 0061922184 was an autopsy performed? if so, can it be provided? yes, do not have a copy.Was there an official cause of death? yes, do not have on file.Per the manufacturer's trend data analysis summary (based on analysis of the machine trend data sent in by the customer): approximately 15 min after patient connection the venous pressure dropped from approx.200 mmhg to approx.60 mmhg.The reason why the venous pressure dropped cannot be determined from the trend.However, this drop in pressure is an indication that the venous line got disconnected.The venous pressure fell below the current venous lower limit of 167 mmhg, the machine triggered the alarms 1053 ('venous pressure - lower limit - check access') and 1959 ('venous pressure lower limit (sup)').With these alarms the blood pump stopped, the venous safety clamp closed, and the dialysis machine switched to patient-safe mode.A few seconds later the alarms were manually acknowledged by pressing the corresponding hardware button on the monitor, and the blood pump was restarted.5 minutes and 26 seconds later the blood pump was again stopped by an alarm; it remained stopped until machine was switched to end of therapy mode.The investigation of the trend data of the therapy in question confirms that the machine worked as specified and that there was no malfunction of the dialysis device.

• Brand Name: DIALOG+®
• Common Device Name: DIALYZER
• Manufacturer (Section D): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• MDR Report Key: 20044598
• Report Number: 2521402-2024-00089
• Device Sequence Number: 20844042
• Product Code: KDI
• UDI-Device Identifier: 04046964285608
• UDI-Public: (01)04046964285608
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2024
• Report Date (Section F): 07/24/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 710200S
• Device Lot Number: 123021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/24/2024
• Device Age: 44 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 70 YR
• Patient Sex: Male