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

Model Number 710500K

Device Problem Device Alarm System (1012)

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 12/06/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The machine trend file and all available information has been forwarded to the manufacturer.Additional information has been requested from the facility and the investigation is on-going at this time.A follow up report will be provided when the evaluation results are available.

Event Description

As reported by the user facility: customer reported the needle dislodged from the patient and the machine did not alarm.The patient was set to run on the machine for 4 hrs and at 3:15, it was discovered that the needle dislodged from the patient and was shooting blood into the coat that the patient had on.The nurses stopped the therapy after noticing something was wrong with the patient.Medical intervention was necessary.Clinicians administered normal saline solution.The patient was sent to the emergency room, had several heart attacks, and passed away two days later in the hospital." no alarm was triggered.

• 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: 6173396
• MDR Text Key: 62336439
• Report Number: 3002879653-2016-00036
• Device Sequence Number: 1
• Product Code: FKJ
• UDI-Device Identifier: 04046963816483
• UDI-Public: (01)04046963816483
• 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
• Report Date: 12/14/2015,12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 710500K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2015
• Distributor Facility Aware Date: 12/12/2016
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/14/2016
• Date Manufacturer Received: 12/12/2016
• 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): Death; Hospitalization; Other; Required Intervention
• Patient Age: 79 YR