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

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 (b)(6) 2020, 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 (b)(6) 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 #1: it was reported that a service technician calibrated the conductivity sensors of a dialog+ dialysis machine in the course of a service call (b)(6) 2020 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.

• Brand Name: DIALOG+
• Type of Device: DIALYSIS 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 Key: 10119006
• MDR Text Key: 194605474
• Report Number: 3002879653-2020-00002
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 4046963686635
• UDI-Public: (01)4046963686635
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7102072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/04/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization