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

Model Number 710200S

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

Patient Problem Death (1802)

Event Date 09/10/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Neither the device involved nor the trend data has been received for evaluation.The investigation is ongoing at this time.A follow-up report will be filed when the investigation is complete.

Event Description

As reported by the user facility: it was reported that a patient coded while being dialyzed 15 minutes into the treatment.It was reported there were no alarms that sounded and the customer denies any disconnections or any other complications with the dialog machine and components.Patient, male, (b)(6), began outpatient clinic with on (b)(6) 2018.Dialysis ordered three (3) times a week - monday, wednesday and friday.Patient came in (b)(6) 2018 for scheduled dialysis.Patient walked in with walker, having shortness of breath when ambulating, and sitting often when walking in.Patient disclosed to clinician that he drank excessive fluids over the weekend, not complying with his fluid restriction.(b)(6).Patient was brought into dialysis room and vitals were obtained.All were within normal limits.Blood pressure (bp) was 120/70 average, afebrile, appearance and color well.The facility does not assess oxygen levels or have capabilities to do so.Patient presented edema in upper and lower extremities.Patient denied any pain.Dialysis set up and started as ordered.Within 10-15 minutes of treatment, the clinician stated the patient sat straight up and said "i cannot breathe!" clinician started patient on oxygen and called 911 while vitals were being taken.All vitals were still within normal limits.The patient went immediately grey then blue.There were no complaints of pain.Clinician denies the patient being diaphoretic.The emergency squad and paramedics were there in less than 4 minutes.As the paramedic approached, the patient went unconscious.The paramedic and squad began cpr right into the ambulance and went to emergency room (er) immediately.Clinician stated the paramedic called within an hour and stated the patient was in ventricular fibrillation the entire ambulance ride to the emergency room.Patient was declared asystole after several attempts of shock and medication revival.The time of death is unknown.It was reported by the clinician that the patient had extensive co-morbidities prior to beginning outpatient dialysis for his acute kidney failure on (b)(6) 2018.Patient had extensive cardiac history that required him to have a defibrillator placed in 2015 or 2016.He is type ii diabetes mellitus uncontrolled, multiple lower extremity ulcers that resulted into osteomyelitis on one of his heels that put him into the hospital in (b)(6) 2018.He was treated for sepsis and had to have his defibrillator removed due to the colonization of the bacteria around it.After cultures came back negative, another defibrillator was placed before being discharged from hospital.Patient developed acute renal failure in the hospital and received dialysis in the hospital.Patient discharged from hospital (b)(6) 2018.Patient was ordered to receive ancef during dialysis in the last 30 minutes of his treatment through (b)(6) 2018 by infection control physician.Mondays and wednesdays he received 2 grams and on fridays he received 3 grams.His last dose was on (b)(6) 2018.Clinician stated the dialog, blood lines were sequestered, electrolytes and cultures obtained and sent to labs.Awaiting results.

Manufacturer Narrative

(b)(4).Neither the device involved nor the trend data has been received for evaluation.The investigation is ongoing at this time.A follow-up report will be filed when the investigation is complete.Corrected data: there was an administrative error on the initial medical device report.Type of report was checked as 5 - day reportable.This has been corrected to 30 - day.

Event Description

As reported by the user facility: it was reported that a patient coded while being dialyzed 15 minutes into the treatment.It was reported there were no alarms that sounded and the customer denies any disconnections or any other complications with the dialog machine and components.Patient, male, (b)(6), began outpatient clinic with on (b)(6) 2018.Dialysis ordered three (3) times a week - monday, wednesday and friday.Patient came in (b)(6) 2018 for scheduled dialysis.Patient walked in with walker, having shortness of breath when ambulating, and sitting often when walking in.Patient disclosed to clinician that he drank excessive fluids over the weekend, not complying with his fluid restriction.(b)(6).Patient was brought into dialysis room and vitals were obtained.All were within normal limits.Blood pressure (bp) was 120/70 average, afebrile, appearance and color well.The facility does not assess oxygen levels or have capabilities to do so.Patient presented edema in upper and lower extremities.Patient denied any pain.Dialysis set up and started as ordered.Within 10-15 minutes of treatment, the clinician stated the patient sat straight up and said "i cannot breathe!" clinician started patient on oxygen and called 911 while vitals were being taken.All vitals were still within normal limits.The patient went immediately grey then blue.There were no complaints of pain.Clinician denies the patient being diaphoretic.The emergency squad and paramedics were there in less than 4 minutes.As the paramedic approached, the patient went unconscious.The paramedic and squad began cpr right into the ambulance and went to emergency room (er) immediately.Clinician stated the paramedic called within an hour and stated the patient was in ventricular fibrillation the entire ambulance ride to the emergency room.Patient was declared asystole after several attempts of shock and medication revival.The time of death is unknown.It was reported by the clinician that the patient had extensive co-morbidities prior to beginning outpatient dialysis for his acute kidney failure on (b)(6) 2018.Patient had extensive cardiac history that required him to have a defibrillator placed in 2015 or 2016.He is type ii diabetes mellitus uncontrolled, multiple lower extremity ulcers that resulted into osteomyelitis on one of his heels that put him into the hospital in (b)(6) 2018.He was treated for sepsis and had to have his defibrillator removed due to the colonization of the bacteria around it.After cultures came back negative, another defibrillator was placed before being discharged from hospital.Patient developed acute renal failure in the hospital and received dialysis in the hospital.Patient discharged from hospital (b)(6) 2018.Patient was ordered to receive ancef during dialysis in the last 30 minutes of his treatment through (b)(6) 2018 by infection control physician.Mondays and wednesdays he received 2 grams and on fridays he received 3 grams.His last dose was on (b)(6) 2018.Clinician stated the dialog, blood lines were sequestered, electrolytes and cultures obtained and sent to labs.Awaiting results.

Manufacturer Narrative

(b)(4).The dialog+ dialysis machine involved in the event was inspected by the facility's technician.The analysis of the trend data record of the dialog+ machine showed an unobtrusive preparation phase.After having passed the self-test successfully, the machine was in standby mode for 40 minutes before the patient was connected.After the patient was connected, the blood flow was set to 400 ml/min.During the following therapy, which lasted 23 minutes, the alarm "arterial pressure -lower limit" was triggered repeatedly by the dialysis machine, sometimes followed by the alarm "venous pressure - lower limit - check access".These alarms were acknowledged by the user, most times within one minute.Following these alarms, the blood flow was changed by the operator to values between 300 ml/min and 400 ml/min.These alarms indicate that the blood flow of 300 ml/min to 400 ml/min was too high in relation to the blood flow the vascular access (fistula needle or catheter) allowed at that time.The alarms do not imply a malfunction of the dialog+ dialysis machine.The blood was returned to the patient and the therapy was finished 23 minutes after it had started.The inspection of the dialog+ dialysis machine by the facility's technician and the analysis of the trend data do not show any product deviation.The machine operated as intended.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by the user facility: it was reported that a patient coded while being dialyzed 15 minutes into the treatment.It was reported there were no alarms that sounded and the customer denies any disconnections or any other complications with the dialog machine and components.Patient, male, (b)(6) years old, began outpatient clinic with on (b)(6) 2018.Dialysis ordered three (3) times a week - monday, wednesday and friday.Patient came in (b)(6) 2018 for scheduled dialysis.Patient walked in with walker, having shortness of breath when ambulating, and sitting often when walking in.Patient disclosed to clinician that he drank excessive fluids over the weekend, not complying with his fluid restriction.Patient weight was (b)(6).His target weight to be (b)(6).Patient was brought into dialysis room and vitals were obtained.All were within normal limits.Blood pressure (bp) was 120/70 average, afebrile, appearance and color well.The facility does not assess oxygen levels or have capabilities to do so.Patient presented edema in upper and lower extremities.Patient denied any pain.Dialysis set up and started as ordered.Within 10-15 minutes of treatment, the clinician stated the patient sat straight up and said "i cannot breathe!" clinician started patient on oxygen and called 911 while vitals were being taken.All vitals were still within normal limits.The patient went immediately grey then blue.There were no complaints of pain.Clinician denies the patient being diaphoretic.The emergency squad and paramedics were there in less than 4 minutes.As the paramedic approached, the patient went unconscious.The paramedic and squad began cpr right into the ambulance and went to emergency room (er) immediately.Clinician stated the paramedic called within an hour and stated the patient was in ventricular fibrillation the entire ambulance ride to the emergency room.Patient was declared asystole after several attempts of shock and medication revival.The time of death is unknown.It was reported by the clinician that the patient had extensive co-morbidities prior to beginning outpatient dialysis for his acute kidney failure on (b)(6) 2018.Patient had extensive cardiac history that required him to have a defibrillator placed in 2015 or 2016.He is type ii diabetes mellitus uncontrolled, multiple lower extremity ulcers that resulted into osteomyelitis on one of his heals that put him into the hospital in (b)(6) 2018.He was treated for sepsis and had to have his defibrillator removed due to the colonization of the bacteria around it.After cultures came back negative, another defibrillator was placed before being discharged from hospital.Patient developed acute renal failure in the hospital and received dialysis in the hospital.Patient discharged from hospital (b)(6) 2018.Patient was ordered to receive ancef during dialysis in the last 30 minutes of his treatment through (b)(6) 2018 by infection control physician.Mondays and wednesdays he received 2 grams and on fridays he received 3 grams.His last dose was on (b)(6) 2018.Clinician stated the dialog, blood lines were sequestered, electrolytes and cultures obtained and sent to labs.Awaiting results.

• Brand Name: DIALOG+®
• Type of Device: HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• Manufacturer (Section G): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 7872673
• MDR Text Key: 120129311
• Report Number: 3002879653-2018-00006
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04046964285608
• UDI-Public: (01)04046964285608
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 710200S
• Device Catalogue Number: 710200S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2018
• Distributor Facility Aware Date: 09/11/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/28/2018
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 186