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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN AVITUM AG - MELSUNGEN DIALOG+ DIALYSIS MACHINE

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B. BRAUN AVITUM AG - MELSUNGEN DIALOG+ DIALYSIS MACHINE Back to Search Results
Catalog Number 7102072
Device Problem Imprecision (1307)
Patient Problems Pain (1994); Dizziness (2194); Sweating (2444)
Event Date 04/10/2020
Event Type  Injury  
Manufacturer Narrative
This report has been identified as b. Braun medical inc. Internal report # (b)(4). Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b. Braun medical, inc. During the technical inspection 2020-04-11 following the described events, it became evident that the calibration of the conductivity sensors had been incorrect. During the service call 2020-04-09, a conductivity meter was used where the required calibration interval was expired. When the conductivity meter was tested and compared with a correctly calibrated measuring device, a deviation of about 1. 25 ms/cm was detected. According to the instructions for use of the conductivity meter, it has to be calibrated every year. The expiry date of the calibration is visible on a sticker applied on this conductivity meter itself. Since the data record of the dialog+ machine as well as the therapy records of the patients could not be provided, it is not finally assessable whether the described symptoms were related to the incorrectly calibrated conductivity sensor or patient-related since the symptoms are not typical for a hyponatremia. With currently > 100,000 dialog+ dialysis machines in the market worldwide, the review of the complaint database for the last 10 years did not show any further case at all where a measuring device was incorrectly calibrated potentially leading to a deviation in electrolyte composition of the dialysis fluid. We can confirm that all other conductivity meters in use by the technical service in china are within the calibration period. The conductivity meter used for the calibration of the dialog+ machine complained was re-calibrated. Awareness training of the technician to calibrate measuring devices in time in the future. If additional pertinent information becomes available a follow-up report will be filed.
 
Event Description
Per user facility: patient #2. It was reported that a service technician calibrated the conductivity sensors of a dialog+ dialysis machine in the course of a service call 2020-04-09. The following day two patients were treated with this dialysis machine. About two hours into therapy both patients complained about feeling uncomfortable, pain in the limbs, sweating, and dizziness. Patient experienced a hyponatremia. The patient recovered after they were treated respectively.
 
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Brand NameDIALOG+
Type of DeviceDIALYSIS MACHINE
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, gm D-342 12
GM D-34212
Manufacturer Contact
jonathan severino
824 12th avenue
bethlehem, pa 
7197287
MDR Report Key10119005
MDR Text Key194605133
Report Number3002879653-2020-00003
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number7102072
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/04/2020 Patient Sequence Number: 1
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