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 2016-10-05 for DIALOG A + HE/BIC 710200L manufactured by B. Braun Avitum Ag - Melsungen.
[56543338]
(b)(4). The machine trend files have been requested from the facility, and the investigation is ongoing at this time. A follow-up report will be submitted when the results of the investigation become available.
Patient Sequence No: 1, Text Type: N, H10
[56543339]
As reported by the user facility: reports the machine was set for 0. 6k uf removal. A power outage occurred. When the machine came back on, the treatment continued until the patient complained of cramping. The nurse checked the machine and it was set at 1. 6k. There were no pump alarms. The patient over filtrated. A bolus of 500ml saline was given for the cramps. The patient went home on her own. The machine has since been used on at least 2 or 3 other treatments without any issues. Additional patient info: prescribed weight to be removed - 0. 6. Patient weight before the treatment and after - pre weight: (b)(6) / post weight: (b)(6). Blood pressure pre, during, and post therapy - 140/71; 103/47; 114/45.
Patient Sequence No: 1, Text Type: D, B5
[59239575]
(b)(4). Initially, it was reported that during a therapy, the dialog+ dialysis machine was set to 600 ml ultrafiltration. After a power outage, the machine resumed the therapy. When the patient complained about cramping the nurse checked the machine and noticed that the ultrafiltration was set to 1600 ml. The patient was infused with 500 ml saline and went home on her own. According to the same report, three therapies were run by the facility's biomed after the incident, without any issues. The dialysis machine operated as intended. After a follow up call with the facility, the customer reported the following information: prescribed weight to be removed: 0. 6 kg; patient weight before the treatment: 88. 3; patient weight after treatment: 86. 6; blood pressure, pre, during and post therapy: 140/71, 103/47, 114/45. After a second follow up with the biomed, he reported that the initial information was incorrect. The ultrafiltration on the machine was set at 1200 ml and not 600 ml, as originally reported. He also stated that the setting did not change after the power failed and the machine came back on. The ultrafiltration setting remained at 1200 ml and not 1600 ml as originally reported. All information associated with this event was forwarded to the equipment manufacturer b. Braun (b)(4). Several attempts were made to obtain the machine trend files for that specific therapy, but the facility did not submit the files for evaluation. After a review of the information received, the manufacturer concludes that, based on the fact that three therapies were run without any issues and the ultrafiltration setting remained unchanged after the power outage, the dialog+ dialysis machine did not experience a malfunction and operated as intended. The manufacturer further reports that a deviation from the ultrafiltration goal can also be caused by other factors, which might not be related to the machine. Some of these factors include; the weighing procedure and/or food and drink intake during dialysis. 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 | 3002879653-2016-00029 |
| MDR Report Key | 6001084 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-05 |
| Date of Report | 2016-09-23 |
| Date of Event | 2016-09-22 |
| Date Facility Aware | 2016-09-23 |
| Report Date | 2016-10-31 |
| Date Reported to FDA | 2016-10-31 |
| Date Reported to Mfgr | 2016-10-31 |
| Date Mfgr Received | 2016-10-25 |
| Date Added to Maude | 2016-10-05 |
| 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 |
| 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 | 2016-10-05 |
| 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 | 2016-10-05 |