DIALOG A + 1 BLOOD PUMP 120V 710500K

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-07 for DIALOG A + 1 BLOOD PUMP 120V 710500K manufactured by B. Braun Avitum Ag - Melsungen.

Event Text Entries

[69272520] (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.
Patient Sequence No: 1, Text Type: N, H10


[69272521] 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.
Patient Sequence No: 1, Text Type: D, B5


[73484940] (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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3002879653-2017-00003
MDR Report Key6383928
Report SourceUSER FACILITY
Date Received2017-03-07
Date of Report2017-02-24
Date of Event2017-02-23
Date Facility Aware2017-02-24
Report Date2017-03-30
Date Reported to FDA2017-03-30
Date Reported to Mfgr2017-03-30
Date Mfgr Received2017-02-24
Date Added to Maude2017-03-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS IRIS RATKE
Manufacturer StreetBUSCHBERG 1
Manufacturer CityMELSUNGEN, 34212
Manufacturer CountryGM
Manufacturer Postal34212
Manufacturer Phone661713718
Manufacturer G1B. BRAUN AVITUM AG - MELSUNGEN
Manufacturer StreetSCHWARZENBERGER WEG 73-79
Manufacturer CityMELSUNGEN, D-34212
Manufacturer CountryGM
Manufacturer Postal CodeD-34212
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIALOG A + 1 BLOOD PUMP 120V
Generic NameHEMODIALYSIS SYSTEM,
Product CodeFKJ
Date Received2017-03-07
Catalog Number710500K
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN AVITUM AG - MELSUNGEN
Manufacturer AddressSCHWARZENBERGER WEG 73-79 MELSUNGEN, D-34212 GM D-34212


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-03-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.