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 2016-07-19 for DIALOG A + HE/BIC 710200L manufactured by B. Braun Avitum Ag - Melsungen.
[49948205]
(b)(4). During the review of service data, b. Braun (b)(4) identified a service call that was performed on 01/06/2016. During this call, the customer reported that the patient uf goal was not met during a therapy on the dialog+ dialysis machine (sn (b)(4)). According to the same report, the patient did not show any symptoms. During the service call, the b. Braun technician calibrated the uf pump, tested it and found uf removal to be within tolerance. After a follow up call with the facility to obtain additional information about the incident, the biomed reported that details about the amount of uf deviation were not available. Due to the time lapse, the trend data record of the complained therapy was no longer available for investigation. Based on the information received from the b. Braun technician, the uf deviation is most likely have been associated with the uf pump calibration. However, there are other factors that can contribute to uf deviations, such as, the patient weighing procedure or food and drink intake during dialysis. During this investigation, b. Braun (b)(4) also discovered that the dialog machine sn (b)(4) was impacted by a recall that b. Braun (b)(4) initiated on april 1, 2016. This recall is associated with reports of cracks in the conductivity sensors, which can also potentially cause uf deviations. After a review of the recall acknowledgement documentation received from this facility and b. Braun (b)(4) service records for the inspection of this machine, it has been determined that the conductivity sensors on this machine continue to operate as intended without any deviations. If additional pertinent information becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[49948206]
As reported by the user facility: dialog evolution #(b)(4) v9. 12 wtc 3048 uf set goal not meet. Calibrated uf pump and tested. Uf removal within allowed tolerance. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002879653-2016-00024 |
| MDR Report Key | 5807123 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-19 |
| Date of Report | 2016-01-06 |
| Date of Event | 2016-01-06 |
| Date Facility Aware | 2016-01-06 |
| Report Date | 2016-07-19 |
| Date Reported to FDA | 2016-07-19 |
| Date Reported to Mfgr | 2016-07-19 |
| Date Added to Maude | 2016-07-19 |
| 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 |
| Remedial Action | RC |
| 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 | 2016-07-19 |
| Catalog Number | 710200L |
| Operator | NURSE |
| Device Availability | N |
| 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 | 2016-07-19 |