MAUDE Adverse Event Report: B. BRAUN AVITUM AG - MELSUNGEN DIALOG+® ; HIGH PERMEABILIT

Model Number	710200S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/27/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Exemption number e2015012.B.Braun medical inc (importer) is submitting this report on behalf of b.Braun avitum ag (manufacturer).This report has been identified as b.Braun avitum internal report # (b)(4).Neither the device involved nor the trend date has been received for evaluation.The investigation is ongoing at this time.A follow-up report will be filed when the investigation is complete.
Event or Problem Description
As reported by the user facility: it was reported that a patient a patient was started on one dialysis machine and a blood leak was noted.The patient was moved to a second machine when she started not to feel well.Patient went to the bathroom but did not come out.The nurse opened the bathroom door and found the patient unresponsive on the floor.911 was called and cpr/aed was started.Aed stated shock was not advised.Ems arrived in less than two (2) minutes and ems was unable to get the patient to respond.The patient was a (b)(6) year old female with significant medical history: severe hypertension, type 2 diabetes, and significant cardiac history.No autopsy was performed.The cause of death was sudden cardiac death.The patient was not attached to the machine at the time of the incident.The facility's biomed and risk management did clear machine, however the facility is keeping the machine out of service until the final report is received from b.Braun.The customer did mention that they feel that the bp readings are higher than normal.A system check out has been completed by the clinic's biomed.Conductivity, temperature and uf have been verified and tested per the manufactures specifications.The machine passed all pressure tests and alarm tests.Dialysate culture result<10, endotoxin result <0.2, lyte results all within davita limits.
Additional Manufacturer Narrative
Exemption number e2015012.B.Braun medical inc (importer) is submitting this report on behalf of b.Braun avitum ag (manufacturer).This report has been identified as b.Braun avitum internal report # (b)(4).Neither the device involved nor the trend date has been received for evaluation.The investigation is ongoing at this time.A follow-up report will be filed when the investigation is complete.Corrected data: there was an administrative error on the intial medical device report.Section g7 was checked as 5 - day reportable.This has been corrected to 30 - day.
Event or Problem Description
As reported by the user facility: it was reported that a patient a patient was started on one dialysis machine and a blood leak was noted.The patient was moved to a second machine when she started not to feel well.Patient went to the bathroom but did not come out.The nurse opened the bathroom door and found the patient unresponsive on the floor.Nine-one-nine (911) was called and cpr/aed was started.Aed stated shock was not advised.Ems arrived in less than two (2) minutes and ems was unable to get the patient to respond.The patient was a (b)(6) female with significant medical history: severe hypertension, type 2 diabetes, and significant cardiac history.No autopsy was performed.The cause of death was sudden cardiac death.The patient was not attached to the machine at the time of the incident.The facility's biomed and risk management did clear machine, however the facility is keeping the machine out of service until the final report is received from b.Braun.The customer did mention that they feel that the bp readings are higher than normal.A system check out has been completed by the clinic's biomed.Conductivity, temperature and uf have been verified and tested per the manufactures specifications.The machine passed all pressure tests and alarm tests.Dialysate culture result<10, endotoxin result <0.2, lyte results all within davita limits.
Additional Manufacturer Narrative
Exemption number e2015012.B.Braun medical inc (importer) is submitting this report on behalf of b.Braun avitum ag (manufacturer).This report has been identified as b.Braun avitum internal report # (b)(4).The analysis of the data record of the dialog+ machine shows an unobtrusive preparation phase.The therapy started at 09:00 [hh:mm] (machine time).The blood pressure was measured shortly thereafter to be174/106 mmhg, pulse rate 80 bpm.The machine triggered the alarm "abpm: dia press.Is too high" (alarm code 9103).The blood pump was stopped indicating that an operator was at the machine at this time.About 1 minute later the therapy was continued.The operator changed the desired bicarbonate and final conductivity.Between 09:09 and 09:11, the starts and stops of the blood pump recorded as well as the fact that no more "red" was detected at the venous red detector (rdv) indicating that the patient was disconnected from the dialog+ machine as described by the customer.At about 09:11 the blood pressure was measured again.It was 175/122mmhg and the pulse rate 80 bpm.Again, the high diastolic pressure was alarmed by the dialysis machine.Until the machine was switched to the end of therapy-phase, about 1 hour 30 minutes later, the fluid circulated in the extracorporeal circuit without the patient being connected to the machine again.The data recording of the dialog+ machine did not show any malfunctions.The machine operated as intended.The blood pressure measurement was performed as intended.The patient's high blood was measured and alarmed.The inspection of the dialog+ dialysis machine by the customer's biomed and the analysis of the trend data do not show any product deviation.The machine operated as intended.If additional pertinent information becomes available a follow-up report will be filed.
Event or Problem Description
As reported by the user facility: it was reported that a patient a patient was started on one dialysis machine and a blood leak was noted.The patient was moved to a second machine when she started not to feel well.Patient went to the bathroom but did not come out.The nurse opened the bathroom door and found the patient unresponsive on the floor.911 was called and cpr/aed was started.Aed stated shock was not advised.Ems arrived in less than two (2) minutes and ems was unable to get the patient to respond.The patient wa a (b)(6) female with significant medical history: severe hypertension, type 2 diabetes, and significant cardiac history.No autopsy was performed.The cause of death was sudden cardiac death.The patient was not attached to the machine at the time of the incident.The facility's biomed and risk management did clear machine, however the facility is keeping the machine out of service until the final report is received from b.Braun.The customer did mention that they feel that the bp readings are higher than normal.A system check out has been completed by the clinic's biomed.Conductivity, temperature and uf have been verified and tested per the manufactures speciations.The machine passed all pressure tests and alarm tests.Dialysate culture result<10, endotoxin result <0.2, lyte results all within davita limits.

• Brand Name: DIALOG+®
• Common Device Name: HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• MDR Report Key: 7872668
• Report Number: 3002879653-2018-00007
• Device Sequence Number: 2218306
• Product Code: KDI
• UDI-Device Identifier: 04046964285608
• UDI-Public: (01)04046964285608
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K083460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2018
• Report Date (Section F): 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 710200S
• Device Catalogue Number: 710200S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/11/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 09/11/2018; 09/11/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 09/13/2018; 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 11/21/2018