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

Catalog Number 710200L

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information along with the trend analysis has been requested from the facility and the investigation is ongoing at this time.A follow up report will be submitted when the results of the investigation become available.

Event Description

As reported by the user facility: product: 710200l, serial (b)(4), problem: staff reported that this machine "froze up on us".Occurred (b)(6) 2016.No alarm triggered.Facility confirmed that the patient felt fine and his blood pressure was ok.

Manufacturer Narrative

(b)(4).Customer reported that the screen of the dialog+ dialysis machine (sn (b)(4)) froze about 3.5 hours into therapy, 30 minutes before the therapy was scheduled to be terminated.It was described that neither the touch screen nor the hard keys for the blood pump operated.The user rebooted the dialysis machine, but the situation was not remedied.In addition, it was reported that the blood pump stood still.From the information that was provided, it is concluded that the control elements froze and that the blood pump stopped because the dialysis machine was rebooted by the operator.After rebooting the dialog+ machine, the blood pump has to be started manually, which was not possible since the respective keys did not respond.The customer report also indicated that due to the long wait, the blood coagulated in the extracorporeal circuit and could not be returned manually with the crank.The patient did not suffer from any symptoms due to the loss of the blood in the extracorporeal circuit and medical intervention was not necessary.According to the same report the dialog+ dialysis machine is in use again without any issues.All information associated with this event was forwarded to the equipment manufacturer b.Braun (b)(4).Neither a component, nor the data record of the therapy were submitted by the facility for investigation.Without having the possibility to investigate the data record of the dialog+ machine, the manufacturer could not determine the exact cause for the unresponsive touch screen and functionless pump control buttons.The monitor of the dialog+ machine is tested during the preparation phase.A defective monitor triggers a warning.Even with an inoperative monitor, a treatment can be terminated since the alarm and control system operates independent from the screen.Therefore, all monitoring functions and the signal lamps on the monitor remain active.The blood pump is checked during the self-test of the dialog+ dialysis machine in the preparation phase.If the blood pump does not operate, the self-test is not passed and a therapy start is not possible.During therapy, the blood-pump is permanently monitored by the supervisor.If the blood pump does not rotate, the supervisor detects this, an alarm is triggered and the machine switches in patient-safe mode.Since the customer indicated that there was no alarm, it is concluded that the blood pump in the current case stopped only after the dialysis machine had been rebooted as outlined above.If the blood pump becomes inoperative during therapy, the customer has the option to return the blood in the extracorporeal circuit using the crank.The respective procedure is described in the operating manual of the dialog+ machine.According to the customer's report the long wait caused the blood to coagulate, which prevented the user to return the blood manually to the patient.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.

• Brand Name: DIALOG A + HE/BIC
• Type of Device: HAEMODIALYSIS 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: tony ribeiro ; 824 12th avenue; bethlehem, PA 18018-0027 ; 6109974717
• MDR Report Key: 5851934
• MDR Text Key: 51350617
• Report Number: 3002879653-2016-00027
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2016,08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 710200L
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2016
• Distributor Facility Aware Date: 08/02/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2016
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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