MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-07-22 for DIALOG A + HE/BIC N/A 710200L manufactured by B. Braun Avitum Ag - Melsungen.
[50290754]
(b)(4). Facility staff reported that during dialysis therapy the patient was fine an then suddenly complained of being short of breath. Patient then became unresponsive. Cpr started by facility staff and 911 was called. Blood was returned to the patient with additional normal saline. Aed was applied, which 'no shock advised', continue cpr. Cpr was continued until ems arrived. When ems arrived, patient was disconnected from dialog. Facility staff also reported that patient had a pulse when she left. Patient was intubated prior to being transported to the hospital. Facility manager was unable to provide patient medical information. Patient current status is unknown by facility manager. Chief biomedical technician obtained dialysate samples with conductivity 13. 8, ph 7. 1. Dialysate samples for electrolytes, colony count, and endotoxins were sent to lab. A follow up report will be provided when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[50290755]
As reported by the user facility: per staff statement," patient was fine an then suddenly complained of being short of breath". Patient then became unresponsive. As a follow up with the facility, the b. Braun (b)(4) clinical manager learned that the patient had just been released from the hospital and the staff felt that the patient was unstable and had questions about the patient receiving the treatment. The facility staff also felt that the machine did not cause the incident, but the patient being unstable. The nurse manager stated about 30 minutes into the treatment the patient started complaining of shortness of breath and difficulty being able to breath. Shortly after the complaints the patient became unresponsive and cpr was started.
Patient Sequence No: 1, Text Type: D, B5
[55025509]
(b)(4). Customer reported that a patient treated with dialog+ dialysis machine (sn (b)(4)) became unresponsive about 30 minutes into therapy. Cardiopulmonary resuscitation (cpr) was initiated by the facility staff. The blood of the extracorporeal circuit was returned with an additional amount of normal saline. The patient was transported to a hospital by emergency medical service (ems). At that time the patient had vital signs. The dialog+ dialysis machine was inspected by the facility technician, supervised by a b. Braun technician. The dialog+ machine operated as intended. There was no malfunction or product deviation. Dialysate samples were taken by the user which is done routinely and the results were: conductivity 13. 8 (normal range 13. 0 - 15. 0) and ph of 7. 1 (normal range 6. 8 - 7. 6). Dialysate samples for electrolytes, colony count, and endotoxins were sent to a lab; however, the results were not disclosed by the facility. After a follow-up call, the facility reported that the patient did not pass away. The patient was transported to hospital with vital signs, and from the description the patient appeared to have had a cardiac arrest. During this call, the facility also stated the patient was post hospital discharge one day and this was her first dialysis since discharge from the hospital. All information and machine trend files associated with this event were forwarded to the equipment manufacturer b. Braun (b)(4). According to their investigation, the analysis of the data record of the dialog+ machine showed that the therapy was started with a blood flow of 200 ml/min and then increased to 400 ml/min. Thereafter the alarm "arterial pressure - lower limit" (alarm code 1051) was triggered several times and acknowledged by the user. Because of the alarms, the dialog+ machine switched into patient- safe mode, the blood pump stopped and the machine operated in bypass. The data record showed that after the increase of the blood flow, the arterial pressure in the extracorporeal circuit continuously decreased. This might have different reasons, as for example, a too high blood flow, an inadequate positioning of the fistula needle or a reduced blood volume due to a hypotensive episode. All these reasons are independent from the machine. After a reduction of the blood flow to 350 ml/min the arterial pressure was higher again and no more alarms occurred until the blood pump was stopped by the user. The blood pump stopped for about a minute, possibly due to the administration of additional volume to the extracorporeal circuit indicated by an increase of the venous pressure. The therapy was continued for another 6 minutes, until uf min was activated and the patient was disconnected from the machine after about 24 minutes of therapy. Neither the inspection of the dialog+ machine nor the trend data show any product deviation or malfunction. 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 | 3002879653-2016-00025 |
| MDR Report Key | 5817581 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-22 |
| Date of Report | 2016-07-20 |
| Date of Event | 2016-07-19 |
| Date Facility Aware | 2016-07-20 |
| Report Date | 2016-09-19 |
| Date Reported to FDA | 2016-09-19 |
| Date Reported to Mfgr | 2016-09-19 |
| Date Mfgr Received | 2016-08-29 |
| Date Added to Maude | 2016-07-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | HAEMODIALYSIS SYSTEM |
| Product Code | FKJ |
| Date Received | 2016-07-22 |
| Model Number | N/A |
| Catalog Number | 710200L |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2016-07-22 |