DIALOG A + 1 BLOOD PUMP 120V 710200K

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-11-15 for DIALOG A + 1 BLOOD PUMP 120V 710200K manufactured by B. Braun Avitum Ag - Melsungen.

Event Text Entries

[59965765] (b)(4). 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


[59965766] As reported by the user facility: patient received hemodialysis post paracentesis procedure, which removed 4. 6 liters of fluid. After 9 minutes (61ml fluid removed) of hemodialysis, patient became unresponsive, rapid response team was called to the bedside, whereby the patient became responsive upon the first chest compression. Was machine alarm triggered: no; patient is a chronic dialysis patient; per physician orders, patient did not resume hemodialysis until the following day; patient was discharged from the hospital the following day after his dialysis was completed.
Patient Sequence No: 1, Text Type: D, B5


[63838632] (b)(4). Customer reported that immediately after a paracentesis with 4. 6 l fluid removal, a patient received hemodialysis with the dialog" hemodialysis machine (sn (b)(4)). About nine minutes into treatment, the patient became unresponsive. Hemodialysis was discontinued. After a follow up call, the customer indicated that the intervention measures included: discontinuation of dialysis; returning the patients blood and; infusing an additional 1,000 ml of saline per physician orders. Patient became responsive upon first chest compression given by the hospital rapid response team. Per physician orders, patient did not resume hemodialysis until the following day. The patient was discharged from the hospital the following day after his dialysis was completed. All information and machine trend files associated with this event were forwarded to the equipment manufacturer b. Braun (b)(4). According to their investigation, the evaluation of the trend data record of the dialog+ dialysis machine matches the description of the customer. After 05:24 [mm:ss] of therapy the machine was switched by the user into bypass, the blood in the extracorporeal circuit was returned and the therapy was terminated. At this time the ultrafiltration volume was 59 ml. The trend data of the therapy showed that the dialog+ machine operated as intended, without any malfunction. According to the medical assessment performed by the manufacturer, the unresponsiveness of the patient is attributable to the high volume depletion during paracentesis. It cannot be attributed to any other medical procedure or to the medical device. 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 Number3002879653-2016-00035
MDR Report Key6103696
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2016-11-15
Date of Report2016-10-21
Date of Event2016-10-17
Date Facility Aware2016-10-21
Report Date2017-01-04
Date Reported to FDA2017-01-04
Date Reported to Mfgr2017-01-04
Date Mfgr Received2016-10-21
Date Added to Maude2016-11-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 Received2016-11-15
Catalog Number710200K
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by Mfgr*
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. Required No Informationntervention 2016-11-15

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