MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2017-01-17 for DIALOG A + HE/BIC 710200L manufactured by B. Braun Avitum Ag - Melsungen.
[65024440]
(b)(4). Initial information was received from the facility biomed and he noted that the machine was not involved in the incident after internal investigation. The machine trend file and 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.
Patient Sequence No: 1, Text Type: N, H10
[65024441]
As reported by the user facility: the male patient was undergoing dialysis treatment. Dialysis machine triggered a blood pressure alarm and patient was noted to be bleeding; evidence of blood was noted. Patient went into cardiac arrest, cpr was started, emergency technicians arrived on scene to resume care, and then declared his death around 1000 am.
Patient Sequence No: 1, Text Type: D, B5
[69447193]
(b)(4). On january 13, 2017, b. Braun (b)(4) received a call from a detective of the lake forrest police department requesting information about the functionality of the dialog+ dialysis machine. During this call, b. Braun (b)(4) learned that a male patient was undergoing dialysis treatment. The dialysis machine triggered a pressure alarm and the patient was noted to be bleeding. The patient went into cardiac arrest and cpr was started. Emergency technicians arrived on scene to resume care, and then declared his death around 10:00 am. After a follow up call with the facility biomed, he confirmed that the venous needle had dislodged and the dialog+ dialysis machine (sn (b)(4)) did trigger an alarm. According to his report, he also checked the machine trend data records and confirmed that there was no malfunction of the dialog+ machine. Multiple attempts were made to obtain additional information from the facility about the circumstances around the event as well as patient information, but the customer indicated that the case was under investigation and they were not allowed to disclose additional details. Meanwhile, all information associated with this event was forwarded to the equipment manufacturer b. Braun (b)(4). According to their report, the trend data record was not provided by the facility for further investigation. However, according to report received from the customer biomed, the device trend files were analyzed by the facility technician and a conclusion was made that the machine operated as intended. The manufacturer reports that the dialog+ dialysis machine will detect a venous needle dislodgement event when the venous pressure drops below the lower venous pressure limit. However, if only a small or no pressure change occurs, depending on the circumstances, and the venous pressure does not fall below the lower limit, the venous pressure monitor might not detect the drop and it might not trigger an alarm. Therefore, the user has to carefully monitor the access side of the patient. In addition, the lower alarm limit for venous pressure monitoring should be set as closely to the current value as possible (e. G. 20 mm hg). If alarm limits are set automatically, they have to be checked and, if necessary, readjusted manually. These properties of a dialysis machine are referenced in the guideline for safe operation of medical equipment used for hemodialysis treatments (iec/tr 62653 edition 1. 0 2012-06) chapter 5. 3. 1 and 5. 3. 3. To account for this functionality, the instructions for use of the dialog+ machine provides the following warning to the user (refer to chapter 5. 3): risk to patient due to blood loss if cannulas get disconnected or slip out! Standard monitoring function of the dialysis machine cannot safely detect that such a situation has arisen! Ensure that the access to the patient always remains fully visible during therapy; ensure that cannulas are adequately fixed; regularly check patient access; venous lower limit should preferably be > 0 mmhg. In summary and based on the information received, the dialog+ hemodialysis machine did trigger a low venous pressure alarm and operated as intended. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002879653-2017-00001 |
| MDR Report Key | 6258665 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2017-01-17 |
| Date of Report | 2017-01-13 |
| Date of Event | 2016-12-01 |
| Date Facility Aware | 2017-01-13 |
| Report Date | 2017-03-08 |
| Date Reported to FDA | 2017-03-08 |
| Date Reported to Mfgr | 2017-03-08 |
| Date Mfgr Received | 2017-01-13 |
| Date Added to Maude | 2017-01-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS IRIS RATKE |
| Manufacturer Street | BUSCHBERG 1 |
| Manufacturer City | MELSUNGEN, 34212 |
| Manufacturer Country | GM |
| Manufacturer Postal | 34212 |
| Manufacturer Phone | 661713718 |
| Manufacturer G1 | B. BRAUN AVITUM AG - MELSUNGEN |
| Manufacturer Street | SCHWARZENBERGER WEG 73-79 |
| Manufacturer City | MELSUNGEN, D-34212 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-34212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIALOG A + HE/BIC |
| Generic Name | HEMODIALYSIS SYSTEM |
| Product Code | FKJ |
| Date Received | 2017-01-17 |
| Catalog Number | 710200L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN AVITUM AG - MELSUNGEN |
| Manufacturer Address | SCHWARZENBERGER WEG 73-79 MELSUNGEN, D-34212 GM D-34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other; 3. Required No Informationntervention | 2017-01-17 |