MAUDE Adverse Event Report: B. BRAUN AVITUM AG - MELSUNGEN DIALOG A + HE/BIC; HEMODIALYSIS SYSTEM

Model Number N/A

Device Problems Inadequate Ultra Filtration (1656); Filtration Problem (2941)

Patient Problems Cramp(s) (2193); Sweating (2444)

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).In a follow up with the facility, it was communicated that the customer's biomed technician ran two simulated therapies with no deviations to the uf result.Based on this, the technician stated that he did not think it was a machine problem.Additionally, the the nurse manager communicated that no malfunctions were noted; no unusual alarms noted in documentation.The investigation into the reported event is on going at this time.A follow up report will be provided when the results of the evaluation become available.

Event Description

As reported by the user facility: event #4: customer called reporting an incident related to ultrifiltation problems with the machine.The customer has retrieved trends from 4 patient runs that have reported problems {[.] the patients complained of cramping.Ems was not required on all 4 accounts.

Manufacturer Narrative

(b)(4).Correction - typographical error : change from :uf/importer report #: 2521402-2014-00017.Change to:uf/importer report #: 2521402-2015-00017.

Manufacturer Narrative

(b)(4).The customer had reported that between (b)(6) 2015, on four patients the weight after dialysis was (b)(6) below target weight.Upon request, the customer did not disclose whether any medical intervention was necessary.The customer suspected the above mentioned dialog+ dialysis machine to be responsible for the overfiltration.The dialog+ dialysis machine was inspected by the customer's technician and two mock therapies were accomplished during which the ultrafiltration was measured.There was no malfunction and no deviation in the ultrafiltration.Ten trend data records of the above mentioned dialog+ machine had been provided by the customer.Six of these data sets showed therapy records, the other four either a preparation phase or a disinfection cycle.The trend data records could not be assigned to a specific event or patient because the customer's corporate facility did not allow therapy protocols or specific patient information to be provided.Four of the trend records show a therapy which was terminated prematurely, in three of these therapies minimal uf had been activated.The analysis of the trend data records do not give any evidence of a malfunction or a product deviation of the dialog+ dialysis machine.Since there is no product deviation, the complained overfiltration might be due to other known reasons which are the weighing procedure before and after dialysis, the residual renal function of a patient or the actual fluid and food intake of a patient during dialysis.Since neither the inspection of the dialog+ dialysis machine on-site nor the evaluation of the trend data record gives any evidence of a malfunction or product deviation, no further measures will be initiated.If additional pertinent information becomes available, a follow up report will be submitted.

• Brand Name: DIALOG A + HE/BIC
• Type of Device: HEMODIALYSIS SYSTEM
• 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, D-342 12; GM D-34212
• Manufacturer Contact: iris ratke ; buschberg 1; melsungen, 34212 ; GM 34212 ; 661713718
• MDR Report Key: 5354550
• MDR Text Key: 35494173
• Report Number: 3002879653-2015-00017
• Device Sequence Number: 1
• Product Code: FKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2016,12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 710200L
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2016
• Distributor Facility Aware Date: 12/18/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/04/2016
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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