DIALOG A +INCL. BIC 710200C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-05-16 for DIALOG A +INCL. BIC 710200C manufactured by B.braun Avitum Ag.

Event Text Entries

[75327779] (b)(4). Initial information was received from the distributor in (b)(6). 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


[75327780] Event #1. As reported by the user facility in (b)(6): ultrafiltration (uf) deviation in dialysis machine dialog+ without related alarms. The ultrafiltration was higher than programmed. The patient developed hypotension and cramps during the therapy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002879653-2017-00005
MDR Report Key6569385
Report SourceFOREIGN,USER FACILITY
Date Received2017-05-16
Date of Report2017-04-18
Date of Event2017-04-03
Date Facility Aware2017-05-12
Report Date2017-08-18
Date Reported to FDA2017-08-18
Date Reported to Mfgr2017-08-18
Date Mfgr Received2017-04-18
Device Manufacturer Date2016-06-10
Date Added to Maude2017-05-16
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 ContactJONATHAN SEVERINO
Manufacturer Street824 10TH AVENUE
Manufacturer CityBETHLEHEM PA 180180027
Manufacturer CountryUS
Manufacturer Postal180180027
Manufacturer Phone4847197287
Manufacturer G1B. BRAUN AVITUM AG (REG #3002879653)
Manufacturer StreetSCHWARZENBERGER WEG 73-79
Manufacturer CityMELSUNGEN 34212
Manufacturer CountryUS
Manufacturer Postal Code34212
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIALOG A +INCL. BIC
Generic NameHEMODIALYSIS SYSTEM
Product CodeFKJ
Date Received2017-05-16
Returned To Mfg2017-05-05
Catalog Number710200C
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age11 MO
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerB.BRAUN AVITUM AG
Manufacturer AddressSCHWARZENBERGER WEG 73-79 MELSUNGEN, 34212 GM 34212


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-05-16

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