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 2016-01-26 for DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC 710200S manufactured by B. Braun Avitum Ag - Melsungen.
[36852044]
(b)(4). Additional information has been requested fromn 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
[36852047]
As reported by the user facility: customer reported an incident of over filtration.
Patient Sequence No: 1, Text Type: D, B5
[46631369]
(b)(4). Customer reported an incident of over filtration. The amount of over filtration was reported to be 0. 6kg. After a follow up call with the facility, the biomed reported that he ran a mock therapy prior to replacing the conductivity sensor and found that machine after 15 minutes was pulling more fluid than expected. According to his report, he did not wait for end of mock therapy and as a consequence, exact values were not recorded. All information associated with this event was forwarded to b. Braun (b)(4) (manufacturer) for further evaluation. Also submitted was the trend data on the machine. Unfortunately, the replaced conductivity sensor was discarded by the biomed and it was not available for evaluation. Their investigation report states that the analysis of the trend data shows potential leakage at the conductivity cells. The analysis showed that air accumulated in the air separator during the whole therapy. This air was separated intermittent and after the 10th opening of the air separator valve vla alarm 1026 was triggered as intended. After further investigation the manufacturer became aware that a limited number of flanges assembled into bicarbonate and end conductivity cells showed hairline cracks. The conductivity sensors are utilized in an area of the dialysis fluid system which is under negative pressure. The negative pressure allows air to be sucked into the dialysis fluid. The air collects in an air separator which forms part of the dialysis fluid system. When the air separator is filled, the air separator valve (vla) opens and the air is purged and replaced by dialysis fluid from outside the balance circuit. The leakage has different consequences dependant upon whether or not the dialog+ hemodialysis machine is equipped with a df-filter or not. For machines with the df filter, the air passes the filter and is collected in the air separator. In dialog machines with df-filter (option df-filter, hdf online machines) the air passes this filter on its way to the air separator. Since air blocks the filter it is flushed out during cyclic filter rinsing, collected in the air separator and flushed out as described. Continuous air entry due to the leakage of the conductivity cells can lead to cyclical pressure fluctuations due to excess air inside the df-filter, thus blocking it. This might lead to an excess uf for the patient ("excessive removal"). The maximum possible amount of the excess uf (theoretical worst case) caused by this failure type was determined in a laboratory setting artificially producing the maximum leakage at which the dialysis machine can be put in therapy. At a dialysis flow of 800 ml/min, the uf deviation was 636 ml/h with the alarm triggered after 55 min of therapy. In addition, 77 conductivity cells returned from the market and showing this failure type were investigated. Sixty four of these cells showed an uf deviation below 200 ml/h and 13 above 200 ml/h at a dialysis fluid flow of 800 ml/min. The maximum uf deviation measured in this case was 488 ml/h. In dialog machines without df-filter the air is also transported to the air separator, where it accumulates and is released as described above. Since there is no df-filter, in these devices no accumulating air might cause an excess uf. The air accumulated in the air separator expands when it is separated and substituted with dialysis fluid from outside the balance circuit. So the fluid volume is bigger than the volume of the compressed air and the uf volume is decreased. Therefore, in devices without df-filter air entry might lead to a too low ultrafiltration ("insufficient removal"). This mechanism occurs also in devices with df-filter but is superimposed by the described cyclical pressure fluctuations inside the df-filter. The amount of insufficient uf caused by this failure type in dialysis machines without df-filter was determined in the above mentioned theoretical worst case setting. The maximum uf deviation in this case was 250 ml/h at a dialysis fluid flow of 800 ml/min. The respective alarm was triggered for the first time after 13 min. To further investigate the uf deviation 24 conductivity cells returned from the market were tested. Three of these conductivity cells showed a deviation between 100 to 200 ml/h with a maximum at 148 ml/h, the other conductivity cells showed lower or no uf deviation. The tests showed that the uf deviations decreased with decreasing dialysis fluid flow. They also imply that the cracks at the conductivity cells develop and increase with time during continuous use of the device. With an increasing leakage, the amount of air sucked into the dialysis fluid system increases and the frequency of the opening of the vla valve. This means that the above described alarm starts to occur first towards the end of a therapy and occurs earlier and earlier with the growth of the crack. If the leakage might approach the maximum, the alarm is triggered early in therapy and more frequently. If the maximum is reached, follow-up alarms will stop the preparation or therapy phase. Root cause: the principle cause of failure of the product is due to variation in molding parameters of the flanges utilized in the construction of the following conductivity sensors. Due to the variation in molding parameters, there is potential for thermal and mechanical stresses during normal operation to induce cracks in the conductivity sensors which causes the ingress of air into the dialysis fluid. Correction: b. Braun (b)(4) have initiated an urgent medical device correction (recall) on april 1, 2016. Action taken to prevent recurrence of problem: b. Braun (b)(4) (manufacturer) has initiated capa (b)(4). (b)(4) has initiated capa (b)(4). If additional pertinent becomes available, a follow up report will be submitted
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002879653-2016-00003 |
| MDR Report Key | 5391698 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-01-26 |
| Date of Report | 2016-01-20 |
| Date of Event | 2016-01-18 |
| Date Facility Aware | 2016-01-20 |
| Report Date | 2016-04-06 |
| Date Reported to FDA | 2016-04-06 |
| Date Reported to Mfgr | 2016-04-06 |
| Date Mfgr Received | 2016-01-20 |
| Date Added to Maude | 2016-01-26 |
| 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 + 120 V DF+ADIMEA+WAN-BSL+BIC |
| Generic Name | HEMODIALYSIS SYSTEM |
| Product Code | FKJ |
| Date Received | 2016-01-26 |
| Catalog Number | 710200S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Other | 2016-01-26 |