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 2016-02-22 for DIALOG A + HE/BIC N/A 710200L manufactured by B. Braun Avitum Ag - Melsungen.
[38698767]
(b)(4). Additional information has been requested from the facility and the investigation into the reported event is on going at this time. A follow up report will be provided when the results of the evaluation become available.
Patient Sequence No: 1, Text Type: N, H10
[38698768]
As reported by the user facility: customer reported that the machine was used on a patient and they went home lighter than they should have been, approximately 1kg lighter. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[47802647]
(b)(4). In a follow up with the biomed from the facility, it was confirmed that there were no alarms during therapy. No malfunctions were noted. The biomed, reported that he checked the conductivity sensors and throttle valves. No issues were identified. He also ran a mock therapy and found the uf removal to be within 3% of target (within limits). No malfunctions were identified. The machine was released for operation. No components were replaced on the machine. The data record of the dialog+ machine for the complained therapy was not available for investigation, but the technician showed that there was no product deviation and no malfunction. There might be different reasons for a deviation from the patient's target weight which are not related to the dialysis machine. It is known that in general there are various factors which have an influence on the ultrafiltration accuracy, such as food/beverage during therapy, additional volume given to the patient (e. G. Saline solution), etc. Without further information it is not possible to determine if there was an ultrafiltration deviation. The investigation by the technician showed no uf deviation or other defects of the device. Therefore a defect of the device can be excluded since there is no product deviation, no further measures will be started. If additional pertinent information becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002879653-2016-00004 |
| MDR Report Key | 5450900 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-02-22 |
| Date of Report | 2016-02-16 |
| Date of Event | 2016-02-16 |
| Date Facility Aware | 2016-02-16 |
| Report Date | 2016-05-12 |
| Date Reported to FDA | 2016-05-12 |
| Date Reported to Mfgr | 2016-05-12 |
| Date Mfgr Received | 2016-02-16 |
| Date Added to Maude | 2016-02-22 |
| 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 | 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 | HAEMODIALYSIS SYSTEM |
| Product Code | FKJ |
| Date Received | 2016-02-22 |
| Model Number | N/A |
| Catalog Number | 710200L |
| Lot Number | N/A |
| 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 | 2016-02-22 |