MAUDE Adverse Event Report: B. BRAUN AVITUM AG DIALOG®; HIGH PERMEABILIT

Model Number	710200L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/13/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
This report has been identified as b.Braun medical, inc.Internal report number (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.
Event or Problem Description
As reported by the user facility: it was reported that a patient coded during a treatment with a dialog+ dialysis machine and passed away.As per facility policy the customer requested an evaluation of the dialysis machine by the manufacturer.The female patient was a 74 year old with a history of hypertension, diabetes, and end-stage renal disease presented due to generalized weakness and elevated blood pressure.During liver function tests (lfts) increased parameters were noted.She was eventually found to have acute cholecystitis and underwent surgery on (b)(6).The patient was on dialysis for 2.5 hours.She was lethargic but arousable and conversant with a blood pressure of 118/60 at 20:25.At 20:55 the staff was unable to obtain a blood pressure and the patient was unresponsive with shallow and slow respiratory rate.The staff auscultated a faint heartbeat.The patient was place in trendelenburg position, treatment was stopped, and her blood was returned to her along with an addition of 200 ml normal saline.Rrt was called.Rrt was also able to auscultate a faint heartbeat.Patient was an allow natural death, so cpr was not initiated.Cause of death: cardiopulmonary arrest.The dialog+ machine was used for 2 to 3 therapies without any issue after the event described above.In the technical inspection by a b.Braun engineer did not show any malfunction of the dialog+ dialysis machine, it operated as intended.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).It was reported that a patient coded during a treatment with a dialog+ dialysis machine and passed away.As per facility policy the customer requested an evaluation of the dialysis machine by the manufacturer.The product involved in teh reported incident was not returned for evaluation.The data record of the dialog+ machine could not be provided, but as requested by the customer, the dialysis machine was technically inspected by a b.Braun engineer.The inspection did not show any malfunction, it operated as intended.Contrary to the initial information is was confirmed that the patient did not pass away during therapy but afterwards.After the patient was treated, two other patients were treated with the same dialog+ machine without any issue.Further investigation of the complaint was not possible without a sample device.Since there was no product deviation, no further action will was taken.

• Brand Name: DIALOG®
• Common Device Name: HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15209399
• Report Number: 3002879653-2022-00021
• Device Sequence Number: 4581786
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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 Model Number: 710200L
• Device Catalogue Number: 710200L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Patient Sex: Female