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U.S. Department of Health and Human Services

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

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B. BRAUN AVITUM AG - MELSUNGEN DIALOG+®  HIGH PERMEABILIT Back to Search Results
Model Number 710200S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 08/27/2018
Event Type  Death  
Manufacturer Narrative
(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 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.
 
Manufacturer Narrative
(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 initial medical device report. Type of reports was checked as 5 - day reportable. This has been corrected to 30 - day.
 
Event 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.
 
Manufacturer Narrative
(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 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.
 
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Brand NameDIALOG+® 
Type of DeviceHIGH PERMEABILIT
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
jonathan severino
861 marcon blvd
allentown, PA 18109
4847197287
MDR Report Key7872668
MDR Text Key120128852
Report Number3002879653-2018-00007
Device Sequence Number1
Product Code KDI
UDI-Device Identifier04046964285608
UDI-Public(01)04046964285608
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083460
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number710200S
Device Catalogue Number710200S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/21/2018
Distributor Facility Aware Date09/11/2018
Event Location Outpatient Treatment Facility
Date Report to Manufacturer11/21/2018
Date Manufacturer Received09/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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