MAUDE Adverse Event Report: B. BRAUN AVITUM AG - MELSUNGEN DIALOG A + 1 BLOOD PUMP 120V; HEMODIALYSIS SYSTEM,

Catalog Number 710500K

Device Problem Device Alarm System (1012)

Patient Problem Blood Loss (2597)

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The machine trend file and additional information has been requested from the facility and the investigation is on-going at this time.A follow up report will be provided when the evaluation results are available.

Event Description

As reported by the user facility: per (b)(4), "needle dislodgment; customer reported that the patient pulled both needles out of their arm.It was reported that the machine alarmed but the attending personnel said the machine alarm soon enough or fast enough.Patient lost blood and was sent to the emergency room and has since recovered." pump alarmed, venous pressure alarm.Limited information provided.

Manufacturer Narrative

(b)(4).Customer reported that a patient pulled the arterial and venous needle intentionally during a therapy with the dialog+ dialysis machine (sn: (b)(4)).According to the same report, the machine triggered a venous pressure alarm.The patient lost blood and was sent to the emergency room, where he recovered.The facility nurse manager confirmed that the biomed checked the dialog+ dialysis machine and confirmed that there was no malfunction.The machine was released for service.The nurse manager only wanted to know how long it would take the alarm to sound in that particular situation.In order to facilitate the investigation, b.Braun requested additional information about the incident, as well as, the trend data record of the dialog+ machine.However, the facility did not provide this information.All information associated with this event was forwarded to the equipment manufacturer (b)(4).According to their report, if the venous needle is dislodged and the venous pressure drops below the lower venous pressure limit the alarms "venous pressure - lower limit - check access" and "venous pressure lower limit (sup)" are triggered.As a consequence, the dialog+ machine stops the blood pump, closes the safety air clamp and switches into bypass (patient-safe mode).The customer report confirmed that the venous pressure alarm was triggered.Since the arterial needle was also pulled by the patient, there might have also have been a second alarm "arterial pressure - upper limit", because the arterial pressure might have risen above the upper arterial pressure limit.Following this alarm the machine would also switch into patient-safe mode.The time passing from the dislodgement of the needle until the dialog+ machine triggers an alarm depends on the blood flow and the time it takes until the venous pressure drops below its lower threshold and/or the arterial pressure rises above its upper threshold.Without having the possibility to analyze the trend data record of the dialog+ machine, it is not possible to specify the time it took in the actual case until the described alarm was triggered.Any dialysis machine might detect a venous needle dislodgement by the drop of the venous pressure below the lower venous pressure limit as in the current case.If only a small or no pressure change may occur dependent on the circumstances and the venous pressure does not fall below the lower limit, the venous pressure monitor might not detect and alarm a venous needle dislodgement.Therefore, the operator has to monitor the access side carefully.In addition, the lower alarm limit for venous pressure monitoring should be set as closely to the current value as possible (e.G.20 mm hg).These properties of a dialysis machine are referenced in the guideline for safe operation of medical equipment used for hemodialysis treatments (iec/tr 62653 edition 1.0 2012-06) chapter 5.3.1 and 5.3.3.To account for this functionality of a dialysis machine the instructions for use of the dialog+ dialysis machine warns the user in chapter 5.3.As follows: risk to patient due to blood loss if cannulas get disconnected or slip out! standard monitoring function of the dialysis machine cannot safely detect that such a situation has arisen! - ensure that the access to the patient always remains fully visible during therapy.- ensure that cannulas are adequately fixed.- regularly check patient access.- venous lower limit should preferably be > 0 mmhg.Based on the information received, b.Braun concludes that the dialog+ dialysis machine did not show any malfunction and operated as intended as confirmed by the facility.All information concerning this incident has been included in our trend analysis of the product line.A historical review of the customer complaint database, revealed no adverse trends regarding this issue.If additional pertinent information becomes available a follow up report will be submitted.

• Brand Name: DIALOG A + 1 BLOOD PUMP 120V
• Type of Device: HEMODIALYSIS SYSTEM,
• 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: iris ratke ; buschberg 1; melsungen, 34212 ; GM 34212 ; 661713718
• MDR Report Key: 6383928
• MDR Text Key: 69272520
• Report Number: 3002879653-2017-00003
• Device Sequence Number: 1
• Product Code: FKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/30/2017,02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 710500K
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2017
• Distributor Facility Aware Date: 02/24/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/30/2017
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other