MAUDE Adverse Event Report: B. BRAUN AVITUM AG - MELSUNGEN DIALOG A + 1 BLOOD PUMP 120V; HEMODIALYSIS SYSTEM

Catalog Number 700510K

Device Problem Device Alarm System (1012)

Patient Problems Air Embolism (1697); Chills (2191)

Event Date 11/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).In a follow up with the reporter, it was confirmed that the patient was transferred for hyperbaric treatment and released and was back at the dialysis center for treatment.It was also communicated by the customer that the patient received chemotherapy on (b)(6) and thought it could have come from the infusa port.The trend files have been received and the investigation is on going 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: received a call about a patient whose treatment was cut short and was sent to the er.The nurse manager reported that a patient running on a dialysis treatment on (b)(6) 2015 at 7:00 in the morning was complaining about chills and was light headed about 2hrs into the treatment.When the nurse was talking to the patient the patient become red and unresponsive.The patient was given oxygen and saline.The patient responded and became responsive.Ems was called and the patient was transferred to the er at (b)(6) hospital.The hospital ran test on the patient and determined that the patient had an air embolism in the right atrium.The patient was transferred to (b)(6) for hyperbaric treatment and released.The patient was back at the dialysis center for treatment today.It was reported that the machine did not have a sad alarm during the therapy.

Manufacturer Narrative

(b)(4).In a follow up with the facility, it was communicated that the machine was inspected by the customer trained technician and released back into service.It was confirmed that there was no product deviation and no malfunction.The dialog+ dialysis machine operated as intended and was put back into operation.The customer also confirmed that the trend file is no longer available for sending as it was deleted by the customer.All available information was forwarded to the manufacturer for further investigation.Their report states that the facility reported that during the morning shift of (b)(6) 2015 a patient complained of chills and being light headed about 2 hours into therapy.When the nurse was talking to the patient he became red and unresponsive.Oxygen and saline were administered and the patient became responsive again.The patient was transferred to the emergency room at kingston hospital.During the medical examination an air embolism in the right atrium was diagnosed.After hyperbaric treatment the patient recovered and was released from the hospital.It was also reported that the dialysis machine involved in the described event was inspected by the customer's technician.Based on the report, no product deviations or malfunctions were identified.The dialog+ dialysis machine operated as intended and was put back into operation.All information associated with this event was forwarded to the equipment manufacturer b.Braun avitum - (b)(4).Upon request for submission of the machine trend data files, the facility confirmed that the data of the respective therapy could not be provided.Based on the review of the information provided, the manufacturer provided the following report.The dialog+ hemodialysis machine is equipped with a safety air detector (sad) that is responsible to detect air in the venous line.If air is detected, the dialog+ dialysis machine triggers an alarm and closes the safety air clamp to prevent air from entering into the patient.The machine has a two channel safety system.The sad is checked during the preparation phase and continuously monitored during therapy.If there is any defect of the sad, this is detected and alarmed and the dialog+ machine switches into a patient safe mode.It was reported that the safety air detector remained in the dialysis after the technical inspection, which confirms that the dialysis machine continued to operate as intended.Since the inspection of the dialog+ machine did not show any malfunction, the sad operated as intended and it was reported that there was no air alarm and no air seen in the venous line during therapy, it is reasonable to conclude that the air embolism diagnosed in the patient was not caused by the dialog+ dialysis machine.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.Since there is no evidence that the dialog+ dialysis machine caused or contributed to the air embolism and no trends identified, no further measures will be initiated.If additional pertinent information becomes available, a follow up report will be submitted.

• Brand Name: DIALOG A + 1 BLOOD PUMP 120V
• 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: 5268684
• MDR Text Key: 32737444
• Report Number: 3002879653-2015-00012
• Device Sequence Number: 1
• Product Code: FKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/03/2016,11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: 700510K
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2016
• Distributor Facility Aware Date: 11/23/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/03/2016
• Date Manufacturer Received: 11/23/2015
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention